[Federal Register Volume 60, Number 173 (Thursday, September 7, 1995)]
[Proposed Rules]
[Pages 46718-46743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22027]




[[Page 46717]]

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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Parts 864, et al.



Medical Devices; Effective Date of Requirement for Premarket Approval 
for Class III Preamendments Devices; Proposed Rules

  Federal Register / Vol. 60, No. 173 / Thursday, September 7, 1995 / 
Proposed Rules  
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[[Page 46718]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 868, 870, 872, 876, 880, 882, 884, 888, and 890

[Docket No. 95N-0084]
RIN 0910-AA31


Medical Devices; Effective Date of Requirement for Premarket 
Approval for Class III Preamendments Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; opportunity to request a change in 
classification.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require 
the filing of a premarket approval application (PMA) or a notice of 
completion of product development protocol (PDP) for 43 class III 
medical devices. The agency also is summarizing its proposed findings 
regarding the degree of risk of illness or injury designed to be 
eliminated or reduced by requiring the devices to meet the statute's 
approval requirements and the benefits to the public from the use of 
the devices. In addition, FDA is announcing the opportunity for 
interested persons to request the agency to change the classification 
of any of the devices based on new information.

DATES: Written comments by January 5, 1996; request for a change in 
classification by September 22, 1995. FDA intends that, if a final rule 
based on this proposed rule is issued, PMA's will be required to be 
submitted within 90 days of the effective date of the final rule.

ADDRESSES: Submit written comments or requests for a change in 
classification to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4765.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 513 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360c) requires the classification of medical devices into 
one of three regulatory classes: Class I (general controls), class II 
(special controls), and class III (premarket approval). Generally, 
devices that were on the market before May 28, 1976, the date of 
enactment of the Medical Device Amendments of 1976 (the amendments) 
(Pub. L. 94-295), and devices marketed on or after that date that are 
substantially equivalent to such devices, have been classified by FDA. 
For the sake of convenience, this preamble refers to both the devices 
that were on the market before May 28, 1976, and the substantially 
equivalent devices that were marketed on or after that date as 
``preamendments devices.''
    Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the 
requirement that a preamendments device that FDA has classified into 
class III is subject to premarket approval. A preamendments class III 
device may be commercially distributed without an approved PMA or 
notice of completion of a PDP until 90 days after FDA issues a final 
rule requiring premarket approval for the device, or 30 months after 
final classification of the device under section 513 of the act, 
whichever is later. Also, a preamendments device subject to the 
rulemaking procedure under section 515(b) of the act is not required to 
have an approved investigational device exemption (IDE) (21 CFR part 
812) contemporaneous with its interstate distribution until the date 
identified by FDA in the final rule requiring the submission of a PMA 
for the device. At that time, an IDE is required only if a PMA has not 
been submitted or a PDP completed.
    Section 515(b)(2)(A) of the act provides that a proceeding to issue 
a final rule to require premarket approval shall be initiated by 
publication of a notice of proposed rulemaking containing: (1) The 
proposed rule; (2) proposed findings with respect to the degree of risk 
of illness or injury designed to be eliminated or reduced by requiring 
the device to have an approved PMA or a declared completed PDP and the 
benefit to the public from the use of the device; (3) an opportunity 
for the submission of comments on the proposed rule and the proposed 
findings; and (4) an opportunity to request a change in the 
classification of the device based on new information relevant to the 
classification of the device.
    Section 515(b)(2)(B) of the act provides that if FDA receives a 
request for a change in the classification of the device within 15 days 
of the publication of the notice, FDA shall, within 60 days of the 
publication of the notice, consult with the appropriate FDA advisory 
committee and publish a notice denying the request for change of 
classification or announcing its intent to initiate a proceeding to 
reclassify the device under section 513(e) of the act. If FDA does not 
initiate such a proceeding, section 515(b)(3) of the act provides that 
FDA shall, after the close of the comment period on the proposed rule 
and consideration of any comments received, issue a final rule to 
require premarket approval, or publish a notice terminating the 
proceeding. If FDA terminates the proceeding, FDA is required to 
initiate reclassification of the device under section 513(e) of the 
act, unless the reason for termination is that the device is a banned 
device under section 516 of the act (21 U.S.C. 360f).
    If a proposed rule to require premarket approval for a 
preamendments device is made final, section 501(f)(2)(B) of the act (21 
U.S.C. 351(f)(2)(B)) requires that a PMA or a notice of completion of a 
PDP for any such device be filed within 90 days of the date of 
promulgation of the final rule or 30 months after final classification 
of the device under section 513 of the act, whichever is later. If a 
PMA or a notice of completion of a PDP is not filed by the later of the 
two dates, commercial distribution of the device is required to cease. 
The device may, however, be distributed for investigational use if the 
manufacturer, importer, or other sponsor of the device complies with 
the IDE regulations. If a PMA or a notice of completion of a PDP is not 
filed by the later of the two dates, and no IDE is in effect, the 
device is deemed to be adulterated within the meaning of section 
501(f)(1)(A) of the act, and subject to seizure and condemnation under 
section 304 of the act (21 U.S.C. 334) if its distribution continues. 
Shipment of the device in interstate commerce will be subject to 
injunction under section 302 of the act (21 U.S.C. 332), and the 
individuals responsible for such shipment will be subject to 
prosecution under section 303 of the act (21 U.S.C. 333). In the past, 
FDA has requested that manufacturers take action to prevent the further 
use of devices for which no PMA has been filed and may determine that 
such a request is appropriate for the class III devices that are the 
subjects of this regulation.
    The act does not permit an extension of the 90-day period after 
promulgation of a final rule within which an application or a notice is 
required to be filed. The House Report on the amendments states that 
``the thirty month `grace period' afforded after classification of a 
device into class III * * * is sufficient time for manufacturers and 
importers to develop the data and conduct the investigations necessary 
to support an application for premarket 

[[Page 46719]]
approval.'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976).)
    The Safe Medical Devices Act of 1990 (Pub. L. 101-629) (SMDA) added 
new section 515(i) to the act (21 U.S.C. 360e(i)). This section 
requires FDA to review the classification of preamendments class III 
devices for which no final rule has been issued requiring the 
submission of PMA's and to determine whether each device should be 
reclassified into class I or class II or remain in class III. For 
devices remaining in class III, SMDA directed FDA to develop a schedule 
for issuing regulations to require premarket approval. However, the 
SMDA does not prevent FDA from proceeding immediately to rulemaking 
under section 515(b) of the act on specific devices, in the interest of 
public health, independent of the procedures in section 515(i). Indeed, 
proceeding directly to rulemaking under section 515(b) of the act is 
consistent with Congress' objective in enacting section 515(i) i.e., 
that preamendments class III devices for which PMA's have not been 
required either be reclassified to class I or class II or be subject to 
the requirements of premarket approval. Moreover, in this proposal, 
interested persons are being offered the opportunity to request 
reclassification of any of the devices.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a 
notice of availability of a preamendments class III devices strategy 
document. The strategy document set forth FDA's plans for implementing 
the provisions of section 515(i) of the act for preamendments class III 
devices for which FDA had not yet required premarket approval. FDA 
divided this universe of devices into three groups:
    1. Group 1 devices are devices that FDA believes raise significant 
questions of safety and/or effectiveness but are no longer used or are 
very limited in use. FDA's strategy is to call for PMA's for all Group 
1 devices in an omnibus 515(b) rulemaking action. This proposed rule 
implements that strategy and covers all Group 1 devices referenced by 
the May 6, 1994, Federal Register notice.
    2. Group 2 devices are devices that FDA believes have a high 
potential for being reclassified into class II. For these devices, FDA 
has issued an order under section 515(i) of the act requiring 
manufacturers to submit safety and effectiveness information so that 
FDA can make a determination as to whether the devices should be 
reclassified.
    3. Group 3 devices are devices that FDA believes are currently in 
commercial distribution and are not likely candidates for 
reclassification. FDA intends to issue proposed rules to require the 
submission of PMA's for the 15 highest priority devices in this group 
in accordance with the schedule set forth in the strategy document. FDA 
has also issued an order under section 515(i) of the act for the 
remaining 27 Group 3 devices requiring the submission of safety and 
effectiveness information so that FDA can make a determination as to 
whether the devices should be reclassified or retained in class III.

A. Dates New Requirements Apply

    In accordance with section 515(b) of the act, FDA is proposing to 
require that a PMA or a notice of completion of a PDP be filed with the 
agency for class III devices within 90 days after promulgation of any 
final rule based on this proposal. An applicant whose device was 
legally in commercial distribution before May 28, 1976, or whose device 
has been found by FDA to be substantially equivalent to such a device, 
will be permitted to continue marketing such class III devices during 
FDA's review of the PMA or notice of completion of the PDP. FDA intends 
to review any PMA for the device within 180 days, and any notice of 
completion of a PDP for the device within 90 days of the date of 
filing. FDA cautions that, under section 515(d)(1)(B)(i) of the act, 
the agency may not enter into an agreement to extend the review period 
for a PMA beyond 180 days unless the agency finds that ``* * * the 
continued availability of the device is necessary for the public 
health.''
    FDA intends that, under Sec. 812.2(d) (21 CFR 812.2(d)), the 
preamble to any final rule based on this proposal will state that, as 
of the date on which a PMA or a notice of completion of a PDP is 
required to be filed, the exemptions in Sec. 812.2(c)(1) and (c)(2) 
from the requirements of the IDE regulations for preamendments class 
III devices will cease to apply to any device that is: (1) Not legally 
on the market on or before that date, or (2) legally on the market on 
or before that date but for which a PMA or notice of completion of PDP 
is not filed by that date, or for which PMA approval has been denied or 
withdrawn.
    If a PMA or a notice of completion of a PDP for a class III device 
is not filed with FDA within 90 days after the date of promulgation of 
any final rule requiring premarket approval for the device, commercial 
distribution of the device must cease. The device may be distributed 
for investigational use only if the requirements of the IDE regulations 
regarding significant risk devices are met. The requirements for 
significant risk devices include submitting an IDE application to FDA 
for its review and approval. An approved IDE is required to be in 
effect before an investigation of the device may be initiated or 
continued. FDA, therefore, cautions that IDE applications should be 
submitted to FDA at least 30 days before the end of the 90-day period 
after the final rule to avoid interrupting investigations.

B. Proposed Finding With Respect to Risks and Benefits

    As required by section 515(b) of the act, FDA is publishing its 
proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring that these 
devices have an approved PMA or a declared completed PDP; and (2) the 
benefits to the public from the use of the device.
    These findings are based on the reports and recommendations of the 
advisory committees (panels) for the classification of these devices 
along with any additional information that FDA discovers. Additional 
information can be found in the proposed and final rules classifying 
these devices as listed below:

                                                                        
------------------------------------------------------------------------
       Devices---             Proposed rule-            Final rule      
------------------------------------------------------------------------
Hematology/Pathology     September 11, 1979 (44   September 12, 1980 (45
 (21 CFR part 864).       FR 52950).               FR 60576             
Anesthesiology 1982 (21  November 2, 1979 (44 FR  July 16, (47 FR 31130)
 CFR part 868).           63292).                                       
Cardiovascular (21 CFR   March 9, 1979- (44 FR    February 5, 1980 (45  
 part 870).               13284).                  FR 7904)             
Dental (21 CFR part      December 30, 198 (45 FR  August 12, 1987 (52 FR
 872).                    85962).                  30082)               
Gastroenterology-        January 23, 1981 (46 FR  November 23, 1983 (48 
 Urology (21 CFR part     7562).                   FR 53012)            
 876).                                                                  
General Hospital and     August 24, 1979 (44 FR   October 21, 1980 (45  
 Personal Use (21 CFR     49844).                  FR 69678)            
 part 880).                                                             
Neurological (21 CFR     November 28, 1978 (43    September 4, 1979 (44 
 part 882).               FR 55640).               FR 51726)            
Obstetrical and          April 3, 1979-(44 FR     February 26, 1980 (45 
 Gynecological.           19894).                  FR 12682)            

[[Page 46720]]
                                                                        
Orthopedic (21 CFR part  July 2, 1982 (47 FR      September 4, 1987 (52 
 888).                    29052).                  FR 33686)            
Physical Medicine (21    August 28, 1979 (44 FR   November 23, 1983 (48 
 CFR part 890).           50458).                  FR 53032)            
------------------------------------------------------------------------



C. Devices Subject to This Proposal

1. Hematology and Pathology Devices

Automated Differential Cell Counter (Sec. 864.5220)

    (1) Identification. An automated differential cell counter is a 
device used to identify and classify one or more of the formed elements 
of the blood. The device is in class III when intended for uses other 
than to flag or identify specimens containing abnormal blood cells. 
Otherwise, the device is in class II.
    (2) Summary of data. The members of the Hematology and Pathology 
Devices Classification Panel based their recommendation upon the Panel 
members' clinical experience with automated differential cell counters 
and on information presented at a symposium entitled ``Differential 
Counters in Hematology'' held at the Panel meeting. Among the speakers 
at the symposium was Dr. Robert Miller of the Johns Hopkins University 
Medical Center. Dr. Miller discussed difficulties concerning data 
interpretation, precision and accuracy, correlation to reference 
methods and error in terms of coincidence, nonreproducible results, 
nonlinearity, and specific interferences.
    FDA has reviewed medical literature concerning automated 
differential cell counters (Refs. 1 through 5). The medical literature 
reports two basic methodologies for automated differential cell 
counting: Pattern recognition and flow-through techniques. Pattern 
recognition systems microscopically scan a fixed, stained blood film. 
Flow-through systems count and identify cells suspended in a liquid 
medium.
    Pattern recognition systems are handicapped by their lack of 
accuracy (Ref. 1). In one study, 68.8 percent of the abnormal cells 
that the system examined were classified as normal (Ref. 2). An error 
of this sort could result in the failure to detect a pathological blood 
sample (Ref. 1). Several studies (Refs. 3 through 5) show a discrepancy 
between pattern recognition counts and manual counts of monocytes 
(mononuclear leukocytes). It is suggested that the criteria for 
identifying monocytes need to be better defined (Ref. 4). There also 
have been reports of discrepancies between pattern recognition counts 
and manual counts of plasma cells and atypical lymphocytes (Ref. 4). 
The tendency of pattern recognition systems to underestimate the number 
of atypical lymphocytes is ascribed to flaws in the recognition 
criteria. Pattern recognition systems also cause difficulty in blood 
film preparation. Overlapping cells must be avoided, and a uniform 
distribution of cell types must be achieved (Ref. 1).
    Flow-through systems allow a hundredfold increase in the rate at 
which cells are counted. There is imperfect correlation between the 
classification logic systems of the flow-through machines and 
morphological features of the blood cell classes as defined by fixed, 
Romanowsky-stained preparations (Ref. 1). Therefore, these machines 
will fail to classify up to 10 percent of normal cells.
    The device was the subject of a reclassification petition and was 
partially reclassified into class II for the uses listed above. The 
proposed rule for reclassification was published in the Federal 
Register of April 5, 1989 (54 FR 13698) and the final rule was 
published in the Federal Register of June 8, 1990 (55 FR 23510).
    (3) Risks to health.
     Hepatitis infection--Exposure of the user, donor, or 
patient to blood, blood products, or blood aerosols presents a risk of 
hepatitis infection. HIV was unknown in 1979 when the device was 
classified and is also an important risk.
     Misdiagnosis and inappropriate therapy--Failure of the 
device to perform satisfactorily may lead to an error in the diagnosis 
of a blood cell disorder. Inappropriate therapy based on inaccurate 
diagnostic data may place the patient at risk.
2. Anesthesiology Devices

Electroanesthesia Apparatus (Sec. 868.5400)

    (1) Identification. An electroanesthesia apparatus is a device used 
for the induction and maintenance of anesthesia during surgical 
procedures by means of an alternating or pulsed electric current that 
is passed through electrodes fixed to the patient's head.
    (2) Summary of data. The Anesthesiology Devices Classification 
Panel and the Neurological Devices Classification Panel recommended 
that electroanesthesia apparatus be classified into class III 
(premarket approval) because the device presents a potential 
unreasonable risk of illness or injury to the patient. The 
Anesthesiology Devices Classification Panel based its recommendation on 
the insufficient number of domestic studies on human subjects. The 
Panel had not seen any medical data on which to judge the safety and 
effectiveness of the device, and believed that the technique of 
electroanesthesia is not considered a well-established or well-
recognized clinical procedure. The Neurological Devices Classification 
Panel noted that many factors important to the clinical application of 
this technique have not been sufficiently defined. The Neurological 
Devices Classification Panel also based its recommendation on the Panel 
members' experience with the device, and their judgment and knowledge 
of the pertinent literature (Ref. 6). The National Research Council 
recommended that electroanesthesia should be considered as a 
potentially useful adjunct in the maintenance of anesthesia but that 
electroanesthesia should be limited to investigational use until its 
effects, advantages, and standardization can be adequately evaluated.
    (3) Risks to health.
     Electrical shock--Improper electrical grounding may allow 
the patient or operator to receive an electrical shock.
     Damage to central nervous system--Excessively high 
electrical current or voltage could damage the central nervous system 
and cerebral tissues.
     Skin burns--If the electrodes are too small and yield a 
high current density, skin burns may result.
     Skin irritation--Electrode gels or pastes used to 
establish electrical contact between the electrode and the skin may 
cause skin irritation.
     Cardiac or pulmonary interference--The position of the 
electrode on the head may lead to electrical interference with cardiac 
or pulmonary functions in the patient.
3. Cardiovascular Devices

Catheter Balloon Repair Kit (Sec. 870.1350)

    (1) Identification. A catheter balloon repair kit is a device used 
to repair or replace the balloon of a balloon catheter. The kit 
contains the materials, such as glue and balloons, necessary to effect 
the repair or replacement.
    (2) Summary of data. The members of the Cardiovascular Devices 
Classification Panel based their recommendation on the potential 
hazards associated with the inherent properties of the device and on 
their personal knowledge of, and experience with, the device. The Panel 
was not aware of any published literature on this device.

[[Page 46721]]

    (3) Risks to health.
     Gas embolism--Balloon rupture caused by the repair 
material or a leak in the repair material can allow potentially 
debilitating or fatal gas emboli to escape into the bloodstream. -
     Embolism--Pieces of the balloon that break or flake off 
may form potentially debilitating or fatal emboli.
     Thromboembolism--Inadequate blood compatibility of the 
materials used in this device and inadequate surface finish and 
cleanliness can lead to potentially debilitating or fatal 
thromboemboli.
     Cardiac arrhythmias--Toxic substances released from the 
repair material (glue or other adhesive) can trigger cardiac 
arrhythmias (irregularities in heart rhythm).

Trace Microsphere (Sec. 870.1360)

    (1) Identification. A trace microsphere is a radioactively tagged 
nonbiodegradable particle that is intended to be injected into an 
artery or vein and trapped in the capillary bed for the purpose of 
studying blood flood within or to an organ.
    (2) Summary of data. The Panel members based their recommendation 
on the potential hazards associated with the inherent properties of the 
device and on their personal knowledge of, and experience with, the 
device.
    (3) Risks to health.
     Thromboembolism--Inadequate blood compatibility of the 
materials used in the device may lead to potentially debilitating or 
fatal thromboemboli.
     Embolism--If the microspheres are too large or tend to 
clump together, they can lodge in a blood vessel and block the flow of 
blood to an organ.
     Tissue damage--Tissue damage can result from excessive 
radioactivity of the particles.

 Carotid Sinus Nerve Stimulator (Sec. 870.3850)

    (1) Identification. A carotid sinus nerve stimulator is an 
implantable device used to decrease arterial pressure by stimulating 
Hering's nerve at the carotid sinus.
    (2) Summary of data. The Panel members based their recommendation 
on the potential hazards associated with the inherent properties of the 
device and on their personal knowledge of, and experience with, the 
device.
    (3) Risks to health.
     Tissue and blood damage--If the materials, surface finish, 
or cleanliness of this device are inadequate, damage to the blood and 
tissue may result.
     Inability to control blood pressure--Failure of the device 
to stimulate properly can prevent effective control of elevated blood 
pressure.-

High-Energy DC-Defibrillator (Including Paddles) (Sec. 870.5300)

    (1) Identification. A high-energy DC-defibrillator is a device that 
delivers into a 50-ohm test load an electrical shock of greater than 
360 joules of energy used for defibrillating the atria or ventricles of 
the heart or to terminate other cardiac arrhythmias. The device may 
either synchronize the shock with the proper phase of the 
electrocardiogram or may operate asynchronously. The device delivers 
the electrical shock through paddles placed either directly across the 
heart or on the surface of the body.
    (2) Summary of data. The Panel relied upon the potential hazards 
associated with the inherent properties of the device and on the Panel 
members' personal knowledge of, and experience with, the device. In 
addition, the Panel sought information from the medical and scientific 
community, industry, and medical literature (Refs. 20 through 25).
    (3) Risks to health.
     Electrical shock to operator--Improper electrical design 
of the device can lead to a serious electrical shock to the operator.
     Inability to defibrillate or persistence of the 
arrhythmia--Inability to rhythmia may occur because of excessive 
energy, excessive current, insufficient energy, insufficient current, a 
difference between the indicated level of energy and the delivered into 
a 50-ohm load, or excessive leakage current. -
     Inability to defibrillate--Inability to defibrillate may 
occur when certain drugs that can raise the defibrillation threshold 
are used.
     Inability to defibrillate due to paddle design--Inability 
to defibrillate may result from inappropriate paddle size or 
inappropriate paddle location on the subject.
4. Dental Devices
Karaya and Sodium Borate With or Without Acacia Denture Adhesive 
(Sec. 872.3400)
    (1) Identification. A karaya with sodium borate with or without 
acacia denture adhesive is a device composed of karaya and sodium 
borate with or without acacia intended to be applied to the base of a 
denture before the denture is inserted into the patient's mouth. The 
device is used to improve denture retention and comfort. If it contains 
12 percent or more by weight of sodium borate, it is in class III; 
otherwise it is in class I.
    (2) Summary of data. The members of the Dental Devices 
Classification Panel relied upon their personal knowledge of, and 
clinical experience with, the device in the practice of dentistry and 
on a report from the then-Bureau of Drugs' OTC Panel on Dentifrices and 
Dental Care Agents (Ref. 26). This report states that there is a lack 
of information concerning the safety of adhesives containing sodium 
borate and a lack of information concerning the effectiveness of acacia 
in denture adhesives. The report states that the sodium borate 
concentration of 12 to 20 percent of the adhesive's total weight is 
equivalent to 2.6 to 5.3 percent boron. Because at least a portion of a 
denture adhesive is ingested, this amount of boron could cause chronic 
toxicity in denture wearers (Ref. 27). The Panel agrees that there is a 
lack of data concerning the safety and effectiveness of acacia and 
karaya with sodium borate.
    (3) Risks to health.
     Chronic toxicity--The boron in this device may cause 
chronic toxicity to users.
     Adverse tissue reaction--If the materials in the device 
are not biocompatible, the patient may have an adverse tissue reaction.
Carboxymethylcellulose Sodium and Cationic Polyacrylamide Polymer 
Denture Adhesive (Sec. 872.3420)
    (1) Identification. A carboxymethylcellulose sodium and cationic 
polyacrylamide polymer denture adhesive is a device composed of 
carboxymethylcellulose sodium and cationic polyacrylamide polymer 
intended to be applied to the base of a denture before the denture is 
inserted in a patient's mouth. The device is used to improve denture 
retention and comfort.
    (2) Summary of data. The Panel based its recommendation on the lack 
of information available to demonstrate the effectiveness of 
carboxymethylcellulose sodium and cationic polyacrylamide in dental 
adhesives and on a report of the then-Bureau of Drugs' OTC Panel on 
Dentifrices and Dental Care Agents. According to the report, the belief 
that carboxymethylcellulose sodium is safe is based, in part, on its 
widespread use in food products such as milk and ice cream (Ref. 28). 
Tests of cationic polyacrylamide for acute oral toxicity, eye 
irritation, and dermal and inhalation toxicity in subacute and chronic 
feeding experiments in animals have been negative (Ref. 26). Human 
patch tests also have been negative (Ref. 28). However, no data were 
submitted to the Panel to demonstrate, and the literature did not 
establish, the effectiveness of carboxymethylcellulose 

[[Page 46722]]
sodium cationic polyacrylamide polymer as a denture adhesive.
    (3) Risks to health.
     Bone loss from lack of effectiveness--If the adhesive 
fails to anchor the denture in its proper position, a change in the 
distance between the upper and lower jaws may occur that may lead to 
gum irritation and bone loss due to alteration of biting forces.
     Adverse tissue reaction--if the materials in the device 
are not biocompatible, the patient may have an adverse tissue reaction.
Polyacrylamide Polymer (Modified Cationic Denture Adhesive 
(Sec. 872.3480)
    (1) Identification. A polyacrylamide polymer (modified cationic) 
denture adhesive is a device composed of polyacrylamide polymer 
(modified cationic) intended to be applied to the base of a denture 
before the denture is inserted in a patient's mouth. The device is used 
to improve denture retention and comfort.
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, 
this device, and on a report of the then-Bureau of Drugs' OTC Panel on 
Dentifrices and Dental Care Agents. Tests of polyacrylamide polymer 
(modified cationic) for acute oral toxicity, eye irritation, and dermal 
and inhalation toxicity in subacute and chronic feeding experiments in 
animals have been negative (Ref. 26). Human patch tests also have been 
negative (Ref. 28). However, no data were submitted to the Panel to 
demonstrate, and the literature did not establish, the effectiveness of 
polyacrylamide polymer as the sole ingredient of a denture adhesive.
    (3) Risks to health.
     Bone loss--If the adhesive fails to anchor the denture in 
its proper position, and the distance between the upper and lower jaw 
is changed, then bone loss and gum irritation may occur.
     Adverse tissue reaction--If the materials in the device 
are not biocompatible, the patient may have an adverse tissue reaction.
Polyvinylmethylether Maleic Anhydride (PVM-MA), Acid Copolymer, and 
Carboxymethylcellulose Sodium (NACMC) Denture Adhesive (Sec. 872.3500)
    (1) Identification. Polyvinylmethylether maleic anhydride (PVM-MA), 
acid copolymer, and carboxymethylcellulose sodium (NACMC) denture 
adhesive is a device composed of polyvinylmethylether maleic anhydride, 
acid copolymer, and carboxymethylcellulose sodium intended to be 
applied to the base of a denture before the denture is inserted in a 
patient's mouth. The device is used to improve denture retention and 
comfort.
    (2) Summary of data. The Panel based it recommendation on the Panel 
members' personal knowledge of, and clinical experience with the device 
and on a report of the then-Bureau of Drugs' OTC Panel on Dentifrices 
and Dental Care Agents. The report states that sufficient data are not 
available to demonstrate the safety and effectiveness of a combination 
of PVM--MA and NACMC used as a denture adhesive (Ref. 26). The Panel 
also based its recommendation on a publication by Blacow (Ref. 27), 
which states that the pH and stability of the anhydride and diacid 
forms may be hazardous due to the possible presence of an acid pH of 2 
to 3, which can burn the tissues in the mouth.
    (3) Risks to health.
     Toxicity--Ingestion of the materials in this device may 
cause chronic toxicity to users.
     Adverse tissue reaction--If the materials in the device 
are not biocompatible, the patient may have an adverse tissue reaction. 
Acidity of the adhesive may burn tissues in the mouth.

Over-the-Counter (OTC) Denture Reliner (Sec. 872.3560)

    (1) Identification. An OTC denture reliner is a device consisting 
of a material such as plastic resin that is intended to be applied as a 
permanent coating or lining on the base or tissue-contacting surface of 
a denture. The device is intended to replace a worn denture lining and 
may be available for purchase over the counter.
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, the 
device. The Panel also based its recommendation on statements that 
further studies are necessary to determine the safety and effectiveness 
of this device (Ref. 26).
    (3) Risks to health.
     Bone degeneration--Use of the device may cause alteration 
in the vertical dimension of a denture and result in bone degeneration 
in the upper and lower jaw.
     Carcinomas--Long-term irritation or oral tissues caused by 
incorrect vertical dimension may cause formation of carcinomas.
Root Canal Filling Resin (Sec. 872.3820)
    (1) Identification. A root canal filling resin is a device composed 
of material, such as methylmethacrylate, intended for use during 
endodontic therapy to fill the root canal of a tooth. If chloroform is 
used as an ingredient in the device, the device is in class III. 
Otherwise, it is in class I.
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, 
root canal filling resins in the practice of dentistry.
    (3) Risks to health. FDA believes that root canal fillings 
containing chloroform present a risk of carcinogenicity.
5. Gastroenterology-Urology Devices

Colonic Irrigation System (Sec. 876.5220)

    (1) Identification. A colonic irrigation system is a device 
intended to instill water into the colon through a nozzle inserted into 
the rectum to cleanse (evacuate) the contents of the lower colon. The 
system is designed to allow evacuation of the contents of the colon 
during the administration of the colonic irrigation. The device 
consists of a container for fluid connected to the nozzle via tubing 
and includes a system which enables the pressure, temperature, or flow 
of water through the nozzle to be controlled. The device may include a 
console-type toilet and necessary fittings to allow the device to be 
connected to water and sewer pipes. The device may use electrical power 
to heat the water. This device does not include the enema kit 
(Sec. 876.5210). When the device is intended for colon cleansing when 
medically indicated, such as before radiologic or endoscopic 
examinations, it is in class II. When the device is intended for other 
uses, including colon cleansing routinely for general well being, it is 
in class III.
    (2) Summary of data. The members of the Gastroenterology-Urology 
Devices Classification Panel based their recommendation on the Panel 
members' personal knowledge of, and clinical experience with, the 
device.
    (3) Risks to health.
     Tissue burns--The temperature-regulating mechanism for the 
water heater used in this device may allow overheating of the water 
which is delivered to the patient's colon, resulting in tissue burns.
     Perforation of the colon--Excessive water pressure 
delivered by this device could result in perforation of the wall of the 
colon.
     Colon irritation--Excessive or inappropriate use of this 
device may result in irritation of the colon.
     Electrical injury--Improper design, construction, or a 
malfunction of the device could result in electrical injury to the 
patient or operator.

[[Page 46723]]


Implanted Electrical Urinary Continence Device (Sec. 876.5270)

    (1) Identification. An implanted electrical urinary continence 
device is a device intended for treatment of urinary incontinence that 
consists of a receiver implanted in the abdomen with electrodes for 
pulsed-stimulation that are implanted either in the bladder wall or in 
the pelvic floor, and a battery-powered transmitter outside the body.
    (2) Summary of data. The Panel based its recommendation on a review 
of the historical data concerning implanted electrical urinary 
continence devices. Halverstadt and Parry (Ref. 29) discussed several 
unsolved problems inherent in the electrical stimulation of the 
bladder. These problems include breakage of lead wires, the cumbersome 
nature of the electrodes, risk of preformation by wires of the bladder 
cavity, difficulty of obtaining uniform contraction of the detrusor 
muscle, and the spread of the stimulus to neighboring tissues producing 
abdominal pain. The Panel also based its recommendation on the 
experimental nature of these devices and on the lack of adequate 
medical literature and experience supporting their safety and 
effectiveness.
    (3) Risks to health.
     Adverse tissue reaction and erosion--Defects in the design 
or the construction of the device, or lack of biocompatibility of the 
materials used in the device, may cause an adverse tissue reaction and 
tissue erosion adjacent to the device.
     Infection--Defects in the design or construction of the 
device preventing adequate cleaning or sterilization, or defects in 
packaging or processing of a device sold as sterile, may allow 
pathogenic organisms to be introduced and cause an infection in the 
patient.
     Tissue damage--Defects in the electrode wires may lead to 
their breakage and consequent tissue damage.
     Abdominal and leg pain--The amount of stimulation by the 
electrodes necessary to obtain adequate bladder stimulation may lead to 
abdominal and leg pain.
     Electrical injury--Improper design, construction, or 
malfunction of the device could result in electrical injury to the 
patient or the operator.
6. General Hospital and Personal Use Devices

Chemical Cold Pack Snakebite Kit (Sec. 880.5760)

    (1) Identification. A chemical cold pack snakebite kit is a device 
consisting of a chemical cold pack and tourniquet used for first-aid 
treatment of snakebites.
    (2) Summary of data. The members of the General Hospital and 
Personal Use Devices Classification Panel based their recommendation on 
the Panel members' personal knowledge of, and clinical experience with, 
the device and on several articles in the literature that evaluate 
different types of treatment for snakebites (Refs. 30, 31, and 32). 
Most of the literature showed that cryotherapy (the use of cold therapy 
for the treatment of snakebites) is inappropriate. Clement and 
Pietrusko found high rates of amputation, local tissue destruction, and 
prolonged disability in patients treated by this method (Ref. 30). A 
National Academy of Sciences report stated that doubts about the safety 
and effectiveness of short-term cold therapy for treatment of 
snakebites have not been resolved (Ref. 31). The report also stated 
that the use of cold therapy for a long period of time appears to be 
dangerous. Watt reported that, among children who had to have 
amputations because of snakebites, 75 percent had received cryotherapy 
for the snakebites (Ref. 32).
    (3) Risks to health.
     Local tissue damage--Exposure of tissue to cold 
temperatures for long periods of time can freeze the tissue and cause 
local tissue damage, sometimes necessitating limb amputations.
7. Neurological Devices

Rheoencephalograph (Sec. 882.1825)

    (1) Identification. A rheoencephalograph is a device used to 
estimate a patient's cerebral circulation (blood flow in the brain) by 
electrical impedance methods with direct electrical connections to the 
scalp or neck area.
    (2) Summary of data. The members of the Neurological Devices 
Classification Panel referenced the literature on this device (Refs. 43 
through 46). Some of the panel members witnessed its clinical 
application. Dr. William Jarzembski, one of the Panel members, provided 
some detailed information concerning his research on this device.
    (3) Risks to health.
     Erroneous clinical conclusions--The device may indicate 
that cerebral circulation is normal, when in fact it may be very 
abnormal.
     Electrical shock--Excessive current could cause injury, 
and malfunction of the device could result in an electrical shock.
     Skin reaction--The electrode materials and conductive 
media may irritate the skin.

Intravascular Occluding Catheter (Sec. 882.5150)

    (1) Identification. An intravascular occluding catheter is a 
catheter with an inflatable or detachable balloon tip that is used to 
block a blood vessel to treat malformations, e.g., aneurysms 
(balloonlike sacs formed on blood vessels) of intracranial blood 
vessels.
    (2) Summary of data. The Panel members based their recommendation 
on the lack of data available on this device. Although the Panel 
members were aware of the use of this device in investigational 
programs, they believed that there is not enough information or data to 
demonstrate that its safety and effectiveness can be adequately 
controlled by means other than premarket approval.
    (3) Risks to health.
     Infarction of nervous tissue--If the catheter is not 
controllable or if the balloon or tip should fail or unexpectedly come 
loose from the catheter, use of the device may cause infarction of 
nervous tissue (death of nervous tissue due to stoppage of circulation) 
and other serious injury to the brain and other nervous tissue.
     Hemorrhage--The catheter or improper balloon inflation may 
injure a blood vessel and result in bleeding.
     Thrombogenesis--Blood coagulation and clotting may result 
if the material of which the catheter is constructed is not compatible 
with blood.

Implanted Spinal Cord Stimulator for Bladder Evacuation (Sec. 882.5850)

    (1) Identification. An implanted spinal cord stimulator for bladder 
evacuation is an electrical stimulator used to empty the bladder of a 
paraplegic patient who has a complete transection of the spinal cord 
and who is unable to empty his or her bladder by reflex means or by the 
intermittent use of catheters. The stimulator consists of an implanted 
receiver with electrodes that are placed on the conus medullaris 
portion of the patient's spinal cord and an external transmitter for 
transmitting the stimulating pulses across the patient's skin to the 
implanted receiver.
    (2) Summary of data. The Panel members based their recommendation 
on information supplied by Dr. Blaine Nashold, one of the Panel 
members, who had been one of the primary individuals engaged in the 
development of the device (Ref. 37). Dr. Nashold reported that he had 
implanted the device in a small group of paraplegic patients. Six of 
the 12 patients had been successfully emptying their bladders by this 
method for 5 years (Ref. 37).
    (3) Risks to health. 

[[Page 46724]]

     Injury to neural tissue--Tissue fibrosis may develop 
around the electrode on the spinal cord and cause a diminished response 
to the electrical stimulus.
     Tissue toxicity--The implanted stimulator, lead wires, or 
electrodes may contain material that is not biocompatible.
     Cerebrospinal fluid leakage--The fluid that surrounds the 
spinal cord might leak out around the receiver wires.
8. Obstetrical and Gynecological Devices

Obstetric Data Analyzer (Sec. 884.2050)

    (1) Identification. An obstetric data analyzer is a device designed 
to interpret fetal status during labor and to warn of possible fetal 
distress by analyzing electronic signal data obtained from fetal or 
maternal electronic or other monitors. This generic type of device 
includes signal analysis and display equipment, electronic interfaces 
for other equipment, and power supplies and component parts.
    (2) Summary of data. FDA reviewed the Obstetrical and Gynecological 
Devices Classification Panel's recommendation and obtained additional 
information and data describing the application of automatic analysis 
techniques to the determination of possible fetal distress. The 
technique was new in 1978, and very little definitive information was 
available. It was reasonable to expect that as algorithms were 
developed and tested, confidence in automatic analysis would increase 
(Ref. 38).
    (3) Risks to health.
     Electrical shock--Malfunction of the device could result 
in electrical shock to the patient.
     Misdiagnosis--Inadequate design or calibration of the 
device could lead to the generation of inaccurate diagnostic data. If 
inaccurate diagnostic data is used in managing the patient, the 
physician may prescribe a course of treatment which places the fetus 
and patient at risk unnecessarily.

Fetal Electroencephalographic Monitor (Sec. 884.2620)

    (1) Identification. A fetal electroencephalographic monitor is a 
device used to detect, measure, and record in graphic form (by means of 
one or more electrodes placed transcervically on the fetal scalp during 
labor) the rhythmically varying electrical skin potentials produced by 
the fetal brain.
    (2) Summary of data. The Panel based its recommendation on the fact 
that fetal electroencephalographic monitoring was a relatively new 
method of brain function evaluation during birth. Its sensitivity and 
applicability in the field of the fetal brain research remained to be 
established because clinical experience was too limited to ascertain 
its safe and effective use. Rosen and Peltzman, who were performing the 
major research on this device, were continuing with further controlled 
studies (Refs. 39 and 40).
    (3) Risks to health.
     Electrical shock--Malfunction of the device could result 
in electrical shock to the patient.
     Misdiagnosis--Inadequate design of the device can lead to 
the generation of inaccurate diagnostic data. If inaccurate diagnostic 
data are used in managing the patient, the physician may prescribe a 
course of treatment that places the fetus and patient at risk 
unnecessarily.
     Adverse tissue reaction--Material in the device could 
result in a systemic or local tissue reaction when the device comes in 
contact with the patient.
     Infection--If the device is not properly sterilized, it 
may introduce microorganisms that could cause infection.

Fetal Scalp Clip Electrode and Applicator (Sec. 884.2685)

    (1) Identification. A fetal scalp clip electrode and applicator is 
a device designed to establish electrical contact between fetal skin 
and an external monitoring device by means of pinching skin tissue with 
a nonreusable clip. This device is used to obtain a fetal 
electrocardiogram. This generic type of device may include a clip 
electrode applicator.
    (2) Summary of data. The Panel based its recommendation on personal 
knowledge of, and experience with, the device. Information presented to 
the Panel indicated a 1 to 2 percent infection rate for newborns on 
whom fetal scalp clip electrodes were used (Ref. 41). The Panel noted 
that this device is in limited use in the United States because the 
circular (spiral) electrode, preferred because it is easier to apply 
and remove, is available.
    (3) Risks to health.
     Adverse tissue reaction--Material in the device could 
cause a local tissue or systemic reaction when the device comes in 
contact with the fetus.
     Infection--If the device is not properly sterilized, it 
may introduce microorganisms that could cause infection.
     Tissue damage--Poor design or incorrect application could 
result in scalp injury when the device pinches the fetal scalp.

Expandable Cervical Dilator (Sec. 884.4250)

    (1) Identification. An expandable cervical dilator is an instrument 
with two handles and two opposing blades used manually to dilate 
(stretch open) the cervix.
    (2) Summary of data. The Panel based its recommendation on personal 
knowledge of, and experience with, the device. The Panel members' 
experience with the expandable cervical dilator had been that its 
leverage is very difficult to control in such a way that the cervix is 
dilated evenly.
    (3) Risks to health.
     Laceration of the cervix--Appropriate design and materials 
are necessary to prevent trauma to the cervix and possible subsequent 
infertility.
     Adverse tissue reaction--Material in the device could 
cause a local tissue or systematic reaction when the device comes in 
contact with the patient.
     Infection--If the device is not properly sterilized, it 
may introduce microorganisms that could cause infection.

Vibratory Cervical Dilator (Sec. 884.4270)

    (1) Identification. A vibratory cervical dilator is a device 
designed to dilate the cervical os by stretching it with a power-driven 
vibrating probe head. The device is used to gain access to the uterus 
or to induce abortion, but is not to be used during labor when a viable 
fetus is desired or anticipated.
    (2) Summary of data. The Panel based its recommendation on 
experience with, and personal knowledge of, the device. The Panel 
reviewed the literature on the device and in a typical study of 50 
patients, there were 3 failures to dilate and 3 patients with cervical 
tears (Ref. 42). The Panel believed that more data concerning these 
types of dilators were necessary before standards could be written.
    (3) Risks to health.
     Laceration of the cervix--Appropriate design and material 
are necessary to prevent trauma to the cervix and possible subsequent 
infertility.
     Electrical shock--Malfunction of the device could result 
in electrical shock to the patient.
     Adverse tissue reaction--Material in the device could 
cause a systemic or local tissue reaction when the device comes in 
contact with the patient.
     Infection--If the device is not properly sterilized, it 
may introduce microorganisms that could cause infection.

[[Page 46725]]


Metreurynter-Balloon Abortion System (Sec. 884.5050)

    (1) Identification. A metreurynter-balloon abortion system is a 
device used to induce abortion. The device is inserted into the uterine 
cavity, inflated, and slowly extracted. The extraction of the balloon 
from the uterus causes dilation of the cervical os. This generic type 
of device may include pressure sources and pressure controls.
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' familiarity with the device and a review of the 
literature on this device. Although journal articles discussing the use 
of this device in Japan indicate that it may be safe and effective 
(Refs. 43 and 44), the Panel believed that these data were inconclusive 
and that more studies needed to be performed to establish the 
performance characteristics of the device. A standard textbook 
mentioned that the device is rarely used because of potential trauma or 
infection, unpredictability, and the risk of a live-born fetus (Ref. 
45).
    (3) Risks to health.
     Infection--If the device is not properly sterilized, it 
may introduce microorganisms that could cause infection.
     Trauma, laceration, hemorrhage, and perforation--Poor 
design of the device could cause uneven dilation of the cervix causing 
injury to the patient.
     Adverse tissue reaction--Material or substances in the 
device could cause a systemic or local tissue reaction when the device 
comes in contact with the patient's cervix.
     Unnecessary medical procedures--Loss of the device could 
result in an otherwise unnecessary medical procedure to recover the 
device from the uterus.

Abdominal Decompression Chamber (Sec. 884.5225)

    (1) Identification. An abdominal decompression chamber is a 
hoodlike device used to reduce pressure on the pregnant patient's 
abdomen for the relief of abdominal pain during pregnancy or labor.
    (2) Summary of data. The Panel based its recommendation on personal 
knowledge of, and experience with, this device. The Panel considered 
this device to be ineffective. Additionally, the Panel found no 
literature available to supply adequate clinical data supporting any 
claim of effectiveness. The consensus of the Panel was that any data 
that might be developed would support an action to ban the device 
because its risks outweigh its benefits.
    (3) Risks to health.
     Difficult patient management--The device is cumbersome and 
covers the abdominal area of the patient, thus blocking the physician 
from examining the patient.
     Supine hypotension--Because the patient is required to lie 
on her back, the possibility of induced low blood pressure and 
consequent complications exists.
9. Orthopedic Devices

Ankle Joint Metal/Polymer Non-Constrained Cemented Prosthesis 
(Sec. 888.3120)

    (1) Identification. An ankle joint metal/polymer non-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
ankle joint. The device limits minimally (less than normal anatomic 
constraints) translation in one or more planes. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have a tibial component made of alloys, such as cobalt-chromium-
molybdenum, and a talar component made of ultra-high molecular weight 
polyethylene, and is limited to those prostheses intended for use with 
bone cement (Sec. 888.3027).
    (2) Summary of data. The members of the Orthopedic Devices 
Classification Panel based their recommendation on the Panel members' 
personal knowledge of the device and on the available medical 
literature. According to Freeman (Ref. 47), ``It is still too early to 
say whether this operation (total ankle joint replacement) offers any 
advantages over arthrodesis * * *. It would appear a comfortable mobile 
ankle can be produced but how reliably this can be done and how long 
the results will last is impossible to say.'' The only available 
clinical study on the device at the time of the Panel meeting had been 
done by Newton (Ref. 48). From 1973 to 1978, 50 patients had this 
prosthesis implanted. There have been 20 (40 percent) reported 
failures. FDA believed these data are insufficient to establish the 
safety and effectiveness of ankle joint metal/polymer non-constrained 
prostheses.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Elbow Joint Humeral (Hemi-Elbow) Metallic Uncemented Prosthesis 
(Sec. 888.3180)

    (1) Identification. An elbow joint humeral (hemi-elbow) metallic 
uncemented prosthesis is a device intended to be implanted, made of 
alloys such as cobalt-chromium-molybdenum, that is used to replace the 
distal end of the humerus formed by the trochlea humeri and the 
capitulum humeri. The generic type of device is limited to prostheses 
intended for use without bone cement (Sec. 888.3027).
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, the 
device. The only available clinical data at the time of the Panel 
meeting were the results of 2 surgeons who had implanted 18 devices 
over a 10-year period (Ref. 49). An earlier publication (Ref. 50) 
discussed the clinical results in what appeared to be the first 10 of 
these 18 implantations. The devices had been implanted in nine patients 
(one patient had prostheses implanted bilaterally). These patients were 
evaluated 1 to 7 years later and only four patients (44 percent) had 
stable, pain-free elbows with a functional range of motion. New bone 
growth restricted or totally blocked elbow joint motion in three 
patients. The device was removed in two other patients; because of 
joint pain and swelling in one; and because the device had dislocated 
and was eroding through the skin in the other.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in the loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and release of materials from the device to the 

[[Page 46726]]
surrounding tissues and systemic circulation.
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Finger Joint Metal/Metal Constrained Uncemented Prosthesis 
(Sec. 888.3200)

    (1) Identification. A finger joint metal/metal constrained 
uncemented prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal (MCP) or proximal interphalangeal (finger) joint. 
The device prevents dislocation in more than one anatomic plane and 
consists of two components which are linked together. This generic type 
of device includes prostheses made of alloys, such as cobalt-chromium-
molybdenum, or protheses made from alloys and ultra-high molecular 
weight polyethylene. This generic type of device is limited to 
prostheses intended for use without bone cement (Sec. 888.3027).
    (2) Summary of data. The only finger joint metal/metal constrained 
uncemented prosthesis discussed in the literature at the time of the 
Panel meeting was a two-pronged stainless steel hinged prostheses that 
was developed by Flatt for use in the MCP and the proximal 
interphalangeal (PIP) joints of the fingers.
    Flatt presented clinical results with the Flatt finger prosthesis 
in a series of publications over a 12-year period (Refs. 51 through 
56). Thirty-one prostheses had been implanted for 6 months or more (6 
months to 34 months); 23 in the PIP joint and 8 in the MCP joint. In 
the earliest of these reports, Flatt noted that despite early 
encouraging clinical results, the long-term outlook for the device did 
not look favorable. In particular, Flatt noted that the bone absorption 
that occurs around the neck of the prosthesis may possibly lead to 
obstruction of flexion. Flatt also noted that possible complications 
from use of the device might be: (a) Bone erosion in patients in whom 
the intramedullary prongs have been forced together in the medullary 
canal, and (b) metal fatigue and fracture of the intramedullary prongs.
    Subsequent publications by Flatt (Refs. 55 and 56) showed that the 
predicted complications did, in fact, occur. Flatt and Ellison (Ref. 
55) reported on the implantation of 242 prostheses (167 in the MCP 
joint and 75 in the PIP joint) with an average followup of 6.2 years 
(range 1 to 12 years). Twenty-six (10.7 percent) of the prostheses (15 
MCP and 11 PIP) had to be removed for the following reasons: 
Periarticular fibrosis (bone resorption) and settling, 14; failure 
(i.e., fracture) of both intramedullary prongs, 2; failure of the screw 
holding the hinge together, 2; breakdown of the skin over the 
prosthesis, 5; and infection, 3. The authors reported that of the 
prostheses that required removal, more than half were removed because 
of settling within the recipient bones. Bone absorption around the 
intramedullary prongs, scarring, or heterotrophic bone formation around 
the hinge caused sufficient mechanical difficulties to necessitate 
removal of the prosthesis. Flatt and Ellison noted that the gradually 
progressing periarticular fibrosis (bone resorption) resulted in a 
decreased range of joint motion and was related to very active use of 
the hand.
    Girzados and Clayton (Ref. 57) reported on the implantation of 23 
Flatt finger prostheses in 11 patients with an average followup of 44 
months (range 24 to 73 months). Of the 23 prostheses implanted, 11 were 
in the MCP joints of the fingers, 8 were in the PIP joints of the 
thumb. Bone absorption around the neck and stems of the prosthesis 
occurred in 16 of the 23 (69 percent) joints. Six prostheses (26 
percent) were rated as poor results: Three had no motion 
postoperatively; one was grossly unstable; and two were implanted in a 
patient with active rheumatoid disease who, over a period of 64 months, 
had intermittent swelling and pain over the joints that had been 
replaced with the prostheses. The authors reported that ``good'' or 
``fair'' results were obtained in 13 (56 percent) of the joints. 
However, the number of patients having pain-free stable joints with a 
useful range of motion (defined as ``good'') as opposed to those with 
limited motion, minimal pain, and instability (defined as ``fair'') 
could not be determined.
    Problems associated with the Flatt finger prosthesis have been 
recognized by many authors (Refs. 58 through 63). Several authors 
(Refs. 58 and 59) reported that these prostheses have not been 
generally accepted because of the accompanying bone resorption. 
McFarland (Ref. 60) reported that the Flatt prosthesis had been only 
moderately successful, that complications were frequent and included 
bone overgrowth with loss of motion, migration of the prosthesis due to 
bone erosion, and metal failures (i.e., device fractures). Goldner and 
Urbaniak (Ref. 62) and Smith and Broudy (Ref. 63) noted that the bone 
resorption and subsequent migration of the devices was caused by the 
use of a rigid material in osteoporotic bone. Smith and Broudy (Ref. 
63) also noted that the intramedullary prongs frequently migrate 
through the cortex and occasionally the hinge would break or the 
overlying skin would ulcerate, causing tendon rupture and infection.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation.
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Finger Joint Metal/Metal Constrained Cemented Prosthesis 
(Sec. 888.3210)

    (1) Identification. A finger joint metal/metal constrained cemented 
prosthesis is a device intended to be implanted to replace a MCP 
(finger) joint. This device prevents dislocation in more than one 
anatomic plane and has components which are linked together. This 
generic type of device include prosthesis that are made of alloys, such 
as cobalt-chromium-molybdenum, and is limited to those prosthesis 
intended for use with bone cement (Sec. 888.3027).
    (2) Summary of data. Two types of these prostheses were discussed 
in the literature: (a) The Link prostheses, a metallic hinge intended 
to replace the MCP joint of a finger or thumb; and (b) the Biomedical 
Laboratories of the University of Cincinnati (BLUC) prostheses, a 
hinged metallic prostheses intended to replace the MCP joint of the 
thumb.
    Devas and Shah (Refs. 64 and 65) reported on the implementation of 
51 Link prostheses in 25 patients with an average postoperative 
followup of 4 years (range 2 to 6 years). In 15 (30 percent) of these 
implantations, the patient had persistent pain in the joint and what 
was described as a useless finger. The authors believed that the 
proportion of patients with pain was far too large to make the 
treatment method freely available. They noted that the main cause of 
failure was due to loosening of the prostheses with disruption 
(erosion) of the bone. They also noted that in most of the joints with 
good and fair results the prosthesis had become loose but that the 
patients were free from symptoms at the time of 

[[Page 46727]]
evaluation. The authors believed that prosthesis loosening may have 
been caused by fixation of the components by injecting the cement into 
the metacarpal and phalangeal bone shafts, and it was noted that a 
modified prosthesis with a different technique of insertion was being 
considered (Ref. 65). Two papers (Refs. 66 and 67) described the design 
and testing of the BLUC thumb prostheses. Clinical results, however, 
were not presented. FDA believed that the data available on the 
devices, the clinical results of the use of the devices in 25 patients 
with a reported failure rate of 30 percent, and the recommendation by 
the authors that the procedure not be made freely available, did not 
establish the long-term safety and effectiveness of finger joint metal/
metal constrained prostheses.
    (3) Risks to health
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation.
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Finger Joint Metal/Polymer Constrained Cemented Prosthesis 
(Sec. 888.3220)

    (1) Identification. A finger joint metal/polymer constrained 
cemented prosthesis is a device intended to be implanted to replace a 
MCP or proximal interphalangeal (finger) joint. The device prevents 
dislocation in more than one anatomic plane, and consists of two 
components which are linked together. This generic type of device 
includes prostheses that are made of alloys, such as cobalt-chromium-
molybdenum, and ultra-high molecular weight polyethylene, and is 
limited to those prostheses intended for use with bone cement 
(Sec. 888.3027).
    (2) Summary of data. Clinical results on three designs of finger 
joint polymer constrained prostheses were presented in the literature: 
The Calnan-Nicolle prosthesis, intended for use in the MCP and PIP 
joints for the fingers; the Niebauer prosthesis also intended for use 
in the MCP and PIP joints of the fingers; and the Swanson prosthesis 
intended for use in the MCP and PIP joints of the fingers and for the 
MCP joint of the thumb.
    a. Calnan-Nicolle prosthesis. This device has two components: An 
across-the-joint component having intramedullary stems and a flexible 
hinge made of polypropylene, and a silicone rubber sleeve which 
encapsulates the flexible hinge portion of the device (Ref. 72). 
Griffiths and Nicolle (Ref. 73) reported on the clinical results 8 to 
37 months (average of 20 months) after implantation of the Calnan-
Nicolle device in 112 MCP joints in 31 patients. Complete relief from 
pain was obtained in four (13 percent) patients. There was much 
improvement over preoperative pain status in 13 (42 percent), moderate 
pain relief in 10 (32 percent), and little pain relief in 4 (13 
percent) patients. These authors reported that a deterioration in the 
performance of the prosthesis occurred in up to half of the patients 
between 1 and 2 years after insertion of the prosthesis; and that part 
of the deterioration in function was due directly to mechanical failure 
of the prosthesis. The range of joint motion had deteriorated over time 
in 33 of the 40 (82.5 percent) hands on which surgery was performed. 
Joint deformity was ``corrected and held'' in 10 to 31 hands (32 
percent), was corrected initially but recurred in 14 of 31 (45 percent) 
hands, and worsened in 7 of 31 (23 percent) hands. The silicone capsule 
(sleeve) had fractured in 31 of the 112 prostheses (28 percent). The 
polypropylene stems had fractured in five joints (5 percent). Nicolle 
(Ref. 71) noted that time and experience had shown that the 
polypropylene hinge of the Calnan-Nicolle prosthesis does not appear to 
be strong enough to withstand fully the compression and torsional 
stresses that may occur in the use of the hand.
    b. Niebauer prosthesis. This device consists of a single, flexible, 
across-the-joint component. The intramedullary stems and the flexible 
hinge portion of the device are made of silicone to allow tissue 
penetration and fixation of the stems. Beckenbaugh et al. (Ref. 75) 
reported on the clinical results 12 to 65 months (average 32 months) 
after implantation in the MCP joints of 68 Niebauer prostheses and 
found a fracture rate of the device of 38.2 percent (26 devices), 
recurrence of clinical deformity in 44.1 percent (30 devices) and 
recurrence of pain in 2 percent. Goldner et al. (Ref. 76) reported a 
fracture rate of 29.7 percent in 37 prostheses implanted for 6.5 years 
and 17.5 percent fracture rate in 143 prostheses implanted 4 to 6 
years. These authors believe that the silicone-polyester material used 
in the device may absorb lipids and become brittle, and that eventual 
fracture of the prosthesis is a possibility, but that fracture does not 
preclude a good functional result. Goldner and Urbaniak (Ref. 77) 
evaluated 103 patients over a 4-year period. Pain was relieved or 
greatly diminished postoperatively in all but 8 of the 103 patients. 
The average active range of motion in these patients was 51 degrees. 
The range of motion was noted to increase up to about 1 year 
postoperatively; and then thought to decrease slightly, possibly due to 
enlarged bony outgrowths from the surface of the bone and impingement 
of peripheral bone on the hinge of the device. In two (2 percent) of 
patients, the device had fractured, which was accompanied by deformity 
and a moderate amount of pain.
    Hagert (Ref. 78) conducted X-ray examinations on 41 joints with 
Niebauer implants. This author reported that of the 41 prostheses 
studied, 26 (63.4 percent) were found to be damaged (i.e., cracked 
within the implant midsection, fragmented at the midsection, or 
fractured at the hinge), 1 to 36 months postoperatively. This author 
believed that the Niebauer implant might be too weak to withstand 
forces in the MCP joints, and that a possible contributing factor was 
the use of materials (polyester fiber and silicone rubber) with 
differing elasticity. This author noted that the Niebauer implant was 
reported to have withstood 100 million flexions during mechanical tests 
bending it around a fixed axis, but not exposing it simultaneously to 
shearing type forces which are present in the MCP joint. These shearing 
forces were reportedly most probably responsible for the deformation of 
the implant and the subsequent damage observed. Niebauer and Landry 
(Ref. 79) reported that destruction of the bone around the hinge of the 
device had occurred in a few cases and that this atrophy may be the 
result of pressure from the prosthesis. In an evaluation by X-ray of 
the 41 Niebauer prostheses, Hagert (Ref. 78) observed bone resorption 
in 23 of the 41 joints (56 percent). The cortex of the bone was 
penetrated in 13 (32 percent) of these joints. It was reported that the 
observed erosion of the bone is most likely caused by motion of the 
intramedullary stems within the medullary cavity, and is exaggerated by 
the rough polyester surface of the device.
    c. Swanson prosthesis. This device is made entirely of silicone 
rubber and is 

[[Page 46728]]
designed to act as an internal mold, maintaining joint alignment, 
becoming encapsulated and stabilized by fibrous tissue, and gliding or 
moving within the medullary cavity rather than being fixed to the bone 
(Ref. 80). A number of reports (Refs. 75 and 80 through 86) were found 
describing the use of the Swanson prostheses in the MCP joints of the 
fingers, but few reports (Refs. 87 through 90) were available 
describing the use of this device in the MCP joint of the thumb, or the 
PIP joints of the fingers. In 1976, it was reported that a new ``high 
performance'' silicone elastomer material had been developed for use in 
the Swanson prosthesis. With the exception of one report (Ref. 90), the 
available clinical data were obtained using prostheses made from the 
``conventional'' silicone elastomer. Fracture of implants made of the 
``conventional'' silicone elastomer appears to be the most frequently 
reported failure. Beckenbaugh et al. (Ref. 75) reported that of 186 
Swanson prostheses implanted in the MCP joint for an average of 32 
months (range 12 months to 65 months), 26.3 percent (49) had fractured. 
Hagert et al. (Ref. 82) reported that of 104 Swanson implants 
evaluated, 25 percent (26) had failed, either by cracking or 
fragmenting and fracturing within the followup period of 1.5 to 5 
years. Mannerfelt and Anderson (Ref. 83) reported a fracture rate of 
2.8 percent in 144 joints evaluated 1.5 to 3.5 years (average 2.5 
years) after implantation. Ferlic et al. (Ref. 84) reported a fracture 
rate of 9 months (average 2.3 years) after implantation. Swanson (Ref. 
80) reported the lowest rate of fracture, 0.88 percent, in a field 
clinic series involving over 3,000 implants with a followup of from 6 
to 30 months.
    The effects of fracture of the device on the clinical results were 
evaluated by several authors. Aptekar et al. (Ref. 85) described the 
occurrence of detritic synovitis (inflammation of the synovial tissue) 
due to shards of silicone rubber found in relation to a broken 
prosthesis. Beckenbaugh et al. (Ref. 75) noted that recurrence of 
deformity was associated with implant fracture, i.e., ulnar drift, in 
14 percent; weakness or instability in 21 percent; hyperextension in 11 
percent; and some clinical deformities in 43 percent; but that while 
the recurrence of deformity implied that soft tissue balance was not 
present after the implant fractured, it was not clear whether the 
imbalance caused the fracture or developed because of it.
    Hagert (Ref. 86) believed that the increased displacement, i.e., 
ulnar deviation, noted in some joints with fractured implants, may 
indicate insufficiency of the fibrous capsule surrounding the implant 
to restrain the forces occurring at the MCP joint. This pressure, 
combined with movement of the implant within the medullary canal was 
reportedly found to cause a moderately progressive bone resorption 
throughout the followup period in all of the 36 joints examined. 
Resorption was observed around the midsection of the prosthesis where 
the implant was in close contact with bone and around the 
intramedullary stems of the device. Erosion of bone around the 
midsection of the device led to various degrees of migration of the 
device in 28 out of 36 (78 percent) of the joints examined. The author 
found that decreased joint flexion was observed due either to the 
distal migration of the implant or a growing volar bony spur in 13 out 
of the 39 (33 percent) joints examined. He concluded that the design of 
the device may be insufficient to fully restrain the volarly and 
proximally directed forces in the MCP joint and the serious decrease of 
flexion. Hagert et al. (Ref. 82) reported that although it is generally 
accepted that silicone rubber absorbs lipids and other substances, the 
effects on material changes and degradation is not adequately known. 
Weightman et al. (Ref. 87) noted that lipid absorption could contribute 
to mechanical failure of the prostheses, as chemical deterioration is 
known to be a prime initiator of fatigue failures of polymers. Other 
clinical results have been reported in the literature (Refs. 80, 81, 
87, and 89) on the use of this prosthesis in large numbers of patients. 
These results were very similar to those summarized previously.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design of 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Hip Joint Metal Constrained Cemented or Uncemented Prosthesis 
(Sec. 888.3300)

    (1) Identification. A hip joint metal constrained cemented or 
uncemented prosthesis is a device intended to be implanted to replace a 
hip joint. The device prevents dislocation in more than one anatomic 
plane and has components that are linked together. This generic type of 
device includes prostheses that have components made of alloys, such as 
cobalt-chromium-molybdenum, and is intended for use with or without 
bone cement (Sec. 888.3027). This device is not intended for biological 
fixation.
    (2) Summary of data. The agency has obtained data and information 
describing the use of hip joint metal constrained prostheses. Sivash 
(Ref. 91) reported on implantation in 164 patients; followup time was 1 
to 9 years. Breakage of the prosthesis was reported in 13 (8 percent) 
of the patients. Because of the lack of adequate data to demonstrate 
the safety and effectiveness of these implanted devices, FDA believed 
that use of the hip joint metal constrained prosthesis presents an 
unreasonable risk of illness or injury.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device, or loosening of the device in the 
surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to a dissolution or wearing away from the surfaces 
of the device and the release of material from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis 
(Sec. 888.3310)

    (1) Identification. A hip joint metal/polymer constrained cemented 
or uncemented prosthesis is a device intended to be implanted to 
replace a hip joint. The device prevents dislocation in more than one 
anatomic plane and has components that are linked together. This 
generic type of device includes prostheses that have a femoral 
component made of alloys, such 

[[Page 46729]]
as cobalt-chromium-molybdenum, and an acetabular component made of 
ultra-high molecular weight polyethylene. This generic type of device 
is intended for use with or without bone cement (Sec. 888.3027). This 
device is not intended for biological fixation.
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, the 
device.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation.
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Hip Joint (Hemi-Hip) Acetabular Metal Cemented Prosthesis 
(Sec. 888.3370)

    (1) Identification. A hip joint (hemi-hip) acetabular metal 
cemented prosthesis is a device intended to be implanted to replace a 
portion of the hip joint. This generic type of device includes 
prostheses that have an acetabular component made of alloys, such as 
cobalt-chromium-molybdenum. This generic type of device is limited to 
those prostheses intended for use with bone cement (Sec. 888.3027).
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, the 
device.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Hip Joint Femoral (Hemi-Hip) Trunnion-Bearing Metal/Polyacetal Cemented 
Prosthesis (Sec. 888.3380)

    (1) Identification. A hip joint femoral (hemi-hip) trunnion-bearing 
metal/polyacetal cemented prosthesis is a two-part device intended to 
be implanted to replace the head and neck of the femur. This generic 
type of device includes prostheses that consist of a metallic stem made 
of alloys, such as cobalt-chromium-molybdenum, with an integrated 
cylindrical trunnion bearing at the upper end of the stem that fits 
into a recess in the head of the device. The head of the device is made 
of polyacetal (polyoxymethylene) and it is covered by a metallic alloy, 
such as cobalt-chromium-molybdenum. The trunnion bearing allows the 
head of the device to rotate on its stem. The prosthesis is intended 
for use with bone cement (Sec. 888.3027).
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, the 
device and on a presentation to the Panel. Dr. Ian Goldie (University 
of Goteborg) presented the results of several Norwegian studies with 
these prostheses. Dr. Goldie referred to Christiansen's series of 241 
hips in which excellent results were obtained in 57 percent of the 
cases and good results in 33 percent. In this series, there were five 
infections, seven cases of loosening of the acetabular cup, two 
dislocations shortly after operation, two cases of femoral perforation, 
and three cases of heterotopic ossification. Dr. Goldie then presented 
the results of his own series of 61 patients. In the 19 patients with 2 
years followup, and in the 28 patients with 6 months followup, there 
were no complications. However, in the remaining 14 patients with a 
followup of 1 year, there were the following complications: 2 
dislocations between the head and the cup, 2 cases of heterotopic 
ossification, and 2 patients with inexplicable pain.
    FDA sought additional data and information on the safety and 
effectiveness of these devices. A review of the medical literature 
revealed a disagreement regarding the resistance to wear of polyacetal 
materials. McKellop et al. (Ref. 92) reported that laboratory wear 
rates for polyacetal ranged from 70 percent lower than polyethylene to 
540 percent higher. Dumbleton (Ref. 93) reported wear in the trunnion 
sleeve of the device and that polyacetal exhibits a low resistance to 
wear. Because of the potential problems involving its resistance to 
wear, the long-term effectiveness of this device is questionable. The 
initial investigator and his associates have been the primary users of 
this device. Long-term followup data are available only from the 
initial investigator. Clinical cases documenting effectiveness and 
safety of the device involve usage of less than 3 years.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction in 
joint function due to excessive wear, fracture, deformation of the 
device components, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility or resistance to wear, may result in an adverse tissue 
reaction due to dissolution or wearing away of the surfaces of the 
device and the release of materials from the device to the surrounding 
tissues and systemic circulation. -
     Infection--The presence of a prosthesis within the body 
may lead to an increased risk of infection.

Knee Joint Femorotibial Metallic Constrained Cemented Prosthesis 
(Sec. 888.3480)

    (1) Identification. A knee joint femorotibial metallic constrained 
cemented prosthesis is a device intended to be implanted to replace 
part of a knee joint. The device prevents dislocation in more than one 
anatomic plane and has components that are linked together. The only 
knee joint movement allowed by the device is in the sagittal plane. 
This generic type of device includes prostheses that have an 
intramedullary stem at both the proximal and distal locations. The 
upper and lower components may be joined either by a solid bolt or pin, 
an internally threaded bolt with locking screw, or a bolt retained by 
circlip. The components of the device are made of alloys, such as 
cobalt-chromium-molybdenum. The stems of the device may be perforated, 
but are intended to be implanted with a polymethylmethacrylate luting 
agent (bone cement).
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and experience with, the device, 
and its 

[[Page 46730]]
review of the medical literature. Results from using the device in more 
than 720 cases have been reported in the medical literature in the 
United States during the past 3 years (Refs. 94, 100, and 103). Reports 
in the medical literature exist that document use of the device in 
several thousand cases worldwide during the past 10 years. The Panel 
believed that this extensive clinical use has revealed the usual 
mechanical problems, implant loosening and settling. The Panel 
determined that the overall risks resulting from use of the prosthesis 
were no worse than the risks associated with major knee surgery without 
implantation of a prosthesis.
    Of the 957 patients reviewed by the Panel who have had this 
prosthesis implanted and who were discussed in the worldwide medical 
literature (Refs. 94 through 105), 108 (11 percent) suffered implant 
failure, 233 (24 percent) of the cases had complications, and 104 (11 
percent) had loosening of the prosthesis.
    FDA sought additional data on the safety and effectiveness of this 
device. Kettelkamp (Ref. 105) reported that the failure rate for the 
device ranges from 5 percent to 24 percent for the hinged metal knee 
prosthesis, with a short followup time. Kettlekamp (Ref. 105) and Chand 
(Ref. 106) both believe that excessive forces may be applied to the 
intramedullary stem bone cement interface because the constrained 
prosthesis hinge prevents medial/lateral joint movement. Kettlekamp 
believes that if the stem loosens, the cement may rub away and destroy 
the surrounding bone, causing a larger cavity and making revision 
difficult or impossible.
    Kettlekamp reviewed reports in the medical literature on use of 576 
Walldius hinged knee prostheses. In one group of 144 implantations, 
complications occurred in 29 cases (13 percent). In the remaining 432 
cases, 89 (20 percent) were classified as failures, 33 (7 percent) 
required reoperations, and 53 (12 percent) had loosening. Fractures 
occurred in 11 cases (2 percent) and deep infection was reported in 35 
knees (8 percent). Kettlekamp reported that the incidence of 
complication increased with the length of reported followup. Brady and 
Garber (Ref. 103) reviewed results of implanting the Shiers design of 
this device in 288 knees. He reported poor results in 71 knees (24 
percent), reoperation was required in 33 knees (11 percent), and 
loosening observed in 56 knees (19 percent). Brady stated that the 
major problems involved with use of these prosthesis are the absence of 
axial (medial) rotation, the necessary resection of large amounts of 
bone, and the creation of physiologic dead space.
    Kettlekamp (Ref. 105) and Deburge et al. (Ref. 107) reported that 
the major problem with the Shiers design prosthesis is loosening. 
Deburge reported a loosening rate of 15 percent (22 patients) during a 
5-year followup of the request of implanting the Guepar constrained 
knee prosthesis in 152 patients. However, less than half of these 
instances of device loosening were symptomatic (10 of 22 patients). 
Reoperations were performed on the 10 patients. Other authors (Ref. 
100) believed that the rate of loosening of the prosthesis is higher, 
possibly around 80 percent, but that only a small percentage of those 
patients with device loosening are symptomatic.
    Arden and Kamdar (Ref. 108) reported followup for 7 years on 
implantation of 193 Shiers design prostheses. They reported that 11 
percent of the patients had aseptic loosening. Kaushal et al. (Ref. 
109) reported followup examination of a series of 30 knees about 42 
months following implantation of the prosthesis. The examination 
revealed that 13 knees (46 percent) had phlebothrombosis, 8 knees (11 
percent) had asymptomatic loosening, 4 knees (5.4 percent) had deep 
infections, and 3 knees (4.3 percent) had symptomatic loosening. The 
major problems with use of the prosthesis were settling, loosening, and 
limitation on the range of joint motion allowed. In preliminary data, 
Van Camp et al. (Ref. 110) showed that stress loading appeared to cause 
mechanical loosening of the device.
    Walker (Ref. 111) stated that the valgus angle of the knee was 
ignored in the older designs of this prosthesis. Walker said this 
design problem resulted in lateral stress on the intramedullary stems 
of the device. This theory was verified experimentally by Wagner and 
Bourgois (Ref. 112). Wagner and Bourgois also showed that, in both the 
Walldius and Shiers designs of the prosthesis, the prosthesis' axis of 
rotation was not equivalent to the axis of the anatomic joint it 
replaced. These researchers said the pin in the Shiers prosthesis was 
turned down on the axis and that it might loosen if the prosthesis were 
overstressed. Because the axle pin of the Walldius prosthesis is 
clamped on one side, the location of the axis causes localized wear.
    Although infection immediately following implantation of a 
prosthesis is primarily a result of surgical technique, Swanson et al. 
(Ref. 113) stated that the design of the prosthesis may minimize the 
rate of infection associated with implantation. Swanson found that the 
infection rate was lower when less bone was removed for insertion of 
the device. Phillips and Taylor (Ref. 98) reported that most groups of 
patients who have received this prosthesis have suffered about a 10 
percent higher incidence of infection than patients in whom other 
generic types of knee prostheses have been implanted.
    In cases of total failure of implantation of a joint prosthesis, 
the prosthesis may be removed and the joint fused (arthrodesis). The 
rate of success in performing arthrodesis is related to the amount of 
bone that was removed to implant the device. Arthrodesis is difficult 
following implantation of a constrained joint replacement device.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented 
Prothesis (Sec. 888.3540)

    (1) Identification. A knee joint patellofemoral polymer/metal semi-
constrained cemented prosthesis is a two-part device intended to be 
implanted to replace part of a knee joint in the treatment of primary 
patellofemoral arthritis or chondromalacia. The device limits 
translation and rotation in one or more planes via the geometry of its 
articulating surfaces. It has no linkage across-the-joint. This generic 
type of device includes a component made of alloys, such as cobalt-
chromium-molybdenum or austenitic steel, for resurfacing the 
intercondylar groove (femoral sulcus) on the anterior aspect of the 
distal femur, and a patellar component made of ultra-high molecular 
weight polyethylene. This generic type of device is limited to those 
devices intended for use with bone cement (Sec. 888.3027). The patellar 
component is designed to be implanted only with its femoral component.

[[Page 46731]]

    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and experience with, similar 
devices and a presentation made to the Panel. Fox reported on his 
clinical experience with this generic type of device. Fox stated that 
patellofemoral joint replacement was performed in more than 60 knees, 
with the followup since 1974. He reported that he, as well as his 
patients, were pleased with the results.
    Other than the presentation to the Panel made by Fox, FDA was not 
aware of any clinical data for this device. Moreover, because Fox 
provided no details regarding the device or its implantation procedure, 
FDA was not certain that the devices Fox implanted belong to this 
generic class.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution of wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Knee Joint Patellofemorotibial Polymer/Metal/Metal Constrained Cemented 
Prosthesis (Sec. 888.3550)

    (1) Identification. A knee joint patellofemorotibial polymer/metal/
metal constrained cemented prosthesis is a device intended to be 
implanted to replace a knee joint. The device prevents dislocation in 
more than one anatomic plane and has components that are linked 
together. This generic type of device includes prostheses that have a 
femoral component, a tibial component, a cylindrical bolt and 
accompanying locking hardware that are all made of alloys, such as 
cobalt-chromium-molybdenum, and a retropatellar resurfacing component 
made of ultra-high molecular weight polyethylene. The retropatellar 
surfacing component may be attached to the resected patella either with 
a metallic screw or luting agent. All stemmed metallic components 
within this generic class are intended to be implanted with a 
polymethylmethacrylate luting agent (bone cement).
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' knowledge of, and experience with, the device and a 
presentation made to the Panel. Pritchard and Fox described their 
experiences with various patellofemoral joint replacing devices 
including this generic type of device. Pritchard has implanted 
patellofemorotibial joint prostheses in at least 100 patients during 
the 3 years prior to the Panel meeting. Also, Fox reported that he has 
achieved good results in over 60 cases since 1974. In May 1962, Young 
(Ref. 116) reported on a series of 16 patients ranging in age from 31 
to 70 years who had a Young design prosthesis implanted (2 were 
bilateral implantations). With a followup time between 9 and 61 months 
(median of 20 months), 7 of these 16 experienced a clinical failure 
(43.8 percent) with a mean time of about 9 months before prosthesis 
removal and arthrodesis (joint fusion). In a later report in 1971, 
Young (Ref. 120) stratified results by indication: At least 3 of 19 
osteoarthritic knees were failures (15.8 percent incidence); at least 
17 of 45 rheumatoid knees failed (37.8 percent incidence); of 4 
replacements for giant-cell tumor, 2 failed (50 percent incidence); and 
at least 6 of 10 traumatic arthritic knees failed (60 percent 
incidence).
    Young noted that nine knees examined sometime after initial 
implantation demonstrated darkening in tissue adjacent to metallic 
components. Young believed that the darkening of tissue was caused by 
tissue contamination from corrosion products. Young also believed that 
similar tissue darkening was noted by Girzadas et al. (Ref. 117). Young 
believed that the darkening was caused by the bolts used in his design 
that were made from a cobalt-based alloy, whereas the other components 
were made from a casting alloy. Young stated that, as a result of his 
survey of the clinical results for 85 physicians who had implanted the 
Young-design prosthesis, he was not optimistic about use of the hinged 
metal/metal knee prostheses and their future for replacement 
arthroplasty.
    In 1973, Hanslik (Ref. 121) reported results of using the device in 
50 patients (two bilaterally implanted), principally for the indication 
of stereoarthrosis. Minimum followup was not given, while maximum 
followup was possibly 4 years. The patients ranged in age from 56 to 76 
years. At least four failures (8 percent) were associated with 
restricted gliding of the patellofemoral articulation: One of these was 
attributed to polymethylmethacrylate-induced bony necrosis. Hanslik 
used the Young (Ref. 116) design of prosthesis and had made major 
modifications in implantation technique as recommended by Friedebold 
and Radloff (Refs. 115, 118, and 120). Hanslik performed partial 
resection of the patella rather than total excision and used a 
polymethylmethacrylate luting agent to grout the medullary stems 
(presumably in addition to the cancellous bone screws recommended by 
Young). Friedebold and Radloff (Ref. 119) reported on use of the 
prosthesis in femorotibial replacement in 11 patients ranging in age 
from 50 to 80 years, with between 6 months and 5 years of followup. 
There were three failures (27.3 percent).
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reactions--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surface of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Knee Joint Femoral (Hemi-Knee) Metallic Uncemented Prosthesis 
(Sec. 888.3570)

    (1) Identification. A knee joint femoral (hemi-knee) metallic 
uncemented prosthesis is a device made of alloys, such as cobalt-
chromium-molybdenum, intended to be implanted to replace part of a knee 
joint. The device limits translation and rotation in one or more planes 
via the geometry of its articulating surfaces. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
consist of a femoral component with or without protuberance(s) for the 
enhancement of fixation and is limited to those prostheses intended for 
use without bone cement (Sec. 888.3027).
    (2) Summary of data. FDA was concerned about both the severity of 
the clinical complications resulting from use of the device and the 
rate at which these complications occur. The agency 

[[Page 46732]]
used the complication classification scheme developed by Fox (Ref. 122) 
and grouped complications by time periods following surgical 
implantation; immediate postoperative complications, within 2 weeks; 
short term, within 24 months; and long term, more than 24 months. Platt 
and Pepler reported in 1969 their clinical results on 55 patients who 
had this prosthesis implanted with up to 10 years followup (Ref. 123). 
Their reported incidence of complications ranged from: General--none 
reported; systemic--none reported; and remote--1 late (2 years 
postoperatively) paranoid schizophrenia (1.8 percent); and (4) local--
at least 45 percent. The most frequent complication was immediate 
postoperative infection with a presumed incidence of 25.5 percent. The 
reoperation rate for this series of patients was reported as 20 out of 
62 knees or 32.4 percent; assuming only 1 reoperation per patient, a 
36.4 percent revision rate will result.
    Aufranc and Jones et al. (Refs. 124 and 125) made extensive 
modifications to M. Smith-Peterson's original ``keeled'' femoral 
condylar mold (Ref. 126) and commenced a series of device implantations 
employing a noncemented stemmed implant in 1952. Clinical results on 64 
patients with a minimum of 1-year followup showed that the incidence of 
complications were: Zero for general and remote categories; 3.1 percent 
for systemic (2 thrombophlebitic episodes); and a minimum of 25 percent 
for cumulated local complications. Matching Platt and Pepler's 
experience (Ref. 124), the most frequent complication observed was 
immediate postoperative infection with a presumed incidence of 20.3 
percent. This series of patients, as of mid-1969, displayed a 
reoperation rate of 14 out of 79 knees (17.7 percent), assuming only 1 
reoperation per patient. Considering this result, with their report of 
16 clinical results rated at less than ``fair,'' the failure rate is 
calculated as 38 percent with an average followup time of 87 months. 
Aufranc and Jones (Ref. 124) noted that 6 of their initial 14 
implantations were failures (42.9 percent) with a maximum followup of 5 
years; apparently 10 more years of surgical experience reduced the 
overall failure rate by 5 percent, without altering the principal 
reported failure modes: Infection and ``poor'' clinical result.
    Further review of available literature (Refs. 108 and 127 through 
136), failed to disclose device experience that would significantly 
alter the trends described above.
    (3) Risks to health.
     Loss or reduction of joint or limb function--Improper 
design or inadequate mechanical properties of the device, such as its 
lack of strength and resistance to wear, may result in the loss or 
reduction of joint function due to excessive wear, fracture, 
deformation of the device, or loosening of the device in the surgical 
cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution of wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and the systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.
     Death--Death may result from lipoembolic sequelae or 
thromboembolic complications during or immediately following 
implantation.

Knee Joint Patellar (Hemi-Knee) Metallic Resurfacing Uncemented 
Prosthesis (Sec. 888.3580)

    (1) Identification. A knee joint patellar (hemi-knee) metallic 
resurfacing uncemented prosthesis is a device made of alloys, such as 
cobalt-chromium-molybdenum, intended to be implanted to replace the 
retropatellar articular surface of the patellofemoral joint. The device 
limits minimally (less than normal anatomic constraints) translation in 
one or more planes. It has no linkage across-the-joint. This generic 
type of device includes prostheses that have a retropatellar 
resurfacing component and an orthopedic screw to transfix the patellar 
remnant. This generic type of device is limited to those prostheses 
intended for use without bone cement (Sec. 888.3027). This device is in 
class III when intended for uses other than treatment of degenerative 
and posttraumatic patellar arthritis; when intended for those uses, it 
is in class II.
    (2) Summary of data. FDA was not aware of any valid scientific 
evidence supporting the safety and effectiveness of this device when 
intended for uses other than the treatment of degenerative and 
posttraumatic patellar arthritis.
    3. Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Shoulder Joint Metal/Metal or Metal/Polymer Constrained Cemented 
Prosthesis (Sec. 888.3640)

    (1) Identification. A shoulder joint metal/metal or metal/polymer 
constrained cemented prosthesis is a device intended to be implanted to 
replace a shoulder joint. The device prevents dislocation in more than 
one anatomic plane and has components that are linked together. This 
generic type of device includes prostheses that have a humeral 
component made of alloys, such as cobalt-chromium-molybdenum, and a 
glenoid component made of this alloy or a combination of this alloy and 
ultra-high molecular weight polyethylene. This generic type of device 
is limited to those prostheses intended for use with bone cement 
(Sec. 888.3027).
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of the device and on their knowledge 
of the medical literature (Refs. 136 through 139). Two of these 
references (Refs. 136 and 137) described a shoulder joint constrained 
prosthesis (Fenlin and Zippel designs) and report that implantation of 
the device relieved pain in 16 of 17 patients. In the patient with the 
painful prosthesis, the authors believed that the device had loosen. 
The times of implantation were not reported.
    Fenlin (Ref. 138) reported that the Fenlin design prosthesis had 
been implanted in five patients. The results in three of these patients 
were discussed. One patient was described as being free of pain, and 
able to use the operated shoulder for all normal activities, except 
those requiring elevation of the arm above 80 deg.. The length of 
followup in this patient was 20 months. Complications were reported in 
the other two patients. In one patient, the device had loosened at 3 
months postoperatively, due to abnormal anatomy of the glenoid. The 
second patient suffered partial nerve palsy due to damage of the 
axillary nerve during surgery. Linscheid and Cofield (Ref. 139) 
reported on the implantation of 13 constrained shoulder joint 
prostheses (6 

[[Page 46733]]
of the Stanmore design, and 7 of the Bickel design). The average time 
of followup was reported as 13 months and ranged from 2 to 26 months. 
There were two cases of dislocations of the Stanmore design prosthesis 
and one case of dislocation of the Bickel design prosthesis. There were 
two additional complications reported with the Bickel design device; 
one case of fracture of the humeral component and one case of loosening 
of the glenoid component.
    FDA sought additional information on the safety and effectiveness 
of these devices. Cofield (Ref. 140) reported that prosthetic 
replacement of the shoulder joint was in 1971, an experimental, 
investigational procedure. This author noted that basic knowledge about 
shoulder biomechanics was limited and that current knowledge of 
shoulder prostheses was not sufficient to establish the requirements of 
a prosthetic replacement. Buechel et al. (Ref. 141) noted that 
complications with current shoulder prostheses have been associated 
with the designs of the devices: (1) The Bickel design shoulder joint 
prosthesis was reported to dislocate and loosen due to the limited 
motion of the prosthesis; and (2) the prosthesis design used by Lettin 
and Scales (presumably the Stanmore design shoulder prosthesis) was 
reported to significantly limit joint motion, then sublux, and 
eventually dislocate at the extremes of normal joint motion. Clinical 
results with several prosthesis designs were reported by Cofield (Ref. 
140, 142, and 143). Eleven persons in whom Bickel design prostheses had 
been implanted were evaluated 18 months to 39 months postoperatively 
(Ref. 142). Three (27 percent) were experiencing significant pain. The 
components of the Bickel device had dislocated in two cases. The 
glenoid component had dislodged from the scapula in two cases and 
loosened in one. The humeral component had fractured in two other 
cases. Reoperation was required in four patients and was needed in two 
or three others. Cofield reported that further clinical and mechanical 
deterioration in these patients was anticipated due to progressive 
loosening of the glenoid components and fatigue fracture of the neck of 
the humeral component, which was not believed to be strong enough. 
These authors concluded that this type of shoulder joint replacement 
(i.e., the Bickel design) is not justified. Cofield (Refs. 140 and 143) 
also reported clinical results in nine patients who had received 
Stanmore prostheses. After an average postoperative time of 1 year 
(ranging between 4 and 18 months), six patients had satisfactory relief 
of pain and three had significant pain. The glenoid component had 
loosened in two patients. FDA concurred with the Panel that the 
reported clinical experience with these devices did not establish their 
long-term safety and effectiveness.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. - -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Shoulder Joint Glenoid (Hemi-Shoulder) Metallic Cemented 
(Sec. 888.3680) Prosthesis

    (1) Identification. A shoulder joint glenoid (hemi-shoulder) 
metallic cemented prosthesis is a device that has a glenoid (socket) 
component made of alloys, such as cobalt-chromium-molybdenum, or alloys 
with ultra-high molecular weight polyethylene and intended to be 
implanted to replace part of a shoulder joint. This generic type of 
device is limited to those prostheses intended for use with bone cement 
(Sec. 888.3027).
    (2) Summary of the data. The Panel based its recommendation on the 
Panel members' personal knowledge of, and clinical experience with, the 
device.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and the release of materials from the device to the 
surrounding tissues and systemic circulation. -
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

Wrist Joint Metal Constrained Cemented Prosthesis (Sec. 888.3790)

    (1) Identification. A wrist joint metal constrained cemented 
prosthesis is a device intended to be implanted to replace a wrist 
joint. The device prevents dislocation in more than one anatomic plane 
and consists of either a single flexible across-the-joint component or 
two components linked together. This generic type of device is limited 
to a device which is made of alloys, such as cobalt-chromium-
molybdenum, and is limited to those prostheses intended for use with 
bone cement (Sec. 888.3027).
    (2) Summary of data. The Panel based its recommendation on the 
Panel members' personal knowledge of the device and on the available 
medical literature. Gschwend et al. (Ref. 144) used this prosthesis in 
15 cases from 1971 through 1975. Fixation was reported to be inadequate 
and not correlated to loads imposed on the wrist joint. In three cases 
(20 percent), the distal stem became loose. The stem fractured in two 
cases (13 percent). On one occasion (6.6 percent) the metacarpal bone 
broke. In another case, as a result of a disturbance of muscle balance, 
the investigators observed a fixed ulnar deviation of the wrist joint 
with a tendency toward radial penetration of the medullary canal of the 
third metacarpal bone. The investigators also described three cases (20 
percent) of a sinking of the prosthesis into the capitate through the 
third metacarpal.
    (3) Risks to health.
     Loss or reduction of joint function--Improper design or 
inadequate mechanical properties of the device, such as its lack of 
strength and resistance to wear, may result in a loss or reduction of 
joint function due to excessive wear, fracture, deformation of the 
device, or loosening of the device in the surgical cavity.
     Adverse tissue reaction--Inadequate biological or 
mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away from the surfaces of 
the device and release of materials from the device to the surrounding 
tissues and systemic circulation.
     Infection--The presence of the prosthesis within the body 
may lead to an increased risk of infection.

[[Page 46734]]

10. Physical Medicine Devices

Rigid Pneumatic Structure Orthosis (Sec. 890.3610)

    (1) Identification. A rigid pneumatic structure orthosis is a 
device intended for medical purposes to provide whole body support by 
means of a pressurized suit to help thoracic paraplegics walk.
    (2) Summary of data. The Panel based its recommendation on the 
literature concerning the device (Refs. 145 and 146). The literature 
evaluation did not demonstrate that the device was safe or effective 
(Ref. 146). The rigid pneumatic structure orthosis was also evaluated 
as requested by the Veterans' Administration and the Rehabilitation 
Services Administration, Department of Health, Education, and Welfare 
(Ref. 146), and did not meet adequate performance standards for safety 
and effectiveness.
    (3) Risks to health.
     Bodily injury--The device could collapse and the patient 
could fall, resulting in bodily injury, if inflation is lost or the 
zippers fail.
     Tissue trauma and/or pressure sores--Tissue trauma and/or 
pressure sores could result if the support beams overinflate and cause 
excessive pressure on the skin of the patient.

II. PMA Requirements

    A PMA for these devices must include the information required by 
section 515(c)(1) of the act. Such a PMA should also include a detailed 
discussion of the risks identified above, as well as a discussion of 
the effectiveness of the device for which premarket approval is sought. 
In addition, a PMA must include all data and information on: (1) Any 
risks known, or that should be reasonably known, to the applicant that 
have not been identified in this document; (2) the effectiveness of the 
device that is the subject of the application; and (3) full reports of 
all preclinical and clinical information from investigations on the 
safety and effectiveness of the device for which premarket approval is 
sought.
    A PMA should include valid scientific evidence obtained from well-
controlled clinical studies, with detailed data, in order to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use.
    Applicants should submit any PMA in accordance with FDA's 
``Premarket Approval (PMA) Manual.'' This manual is available upon 
request from FDA, Center for Devices and Radiological Health, Division 
of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., 
Rockville, MD 20850.

III. Request for Comments with Data

    Interested persons may, on or before January 5, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Opportunity to Request a Change in Classification

    Before requiring the filing of a PMA or a notice of completion of a 
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through 
(b)(2)(A)(iv) of the act and Sec. 860.132 (21 CFR 860.132) to provide 
an opportunity for interested persons to request a change in the 
classification of the device based on new information relevant to its 
classification. Any proceeding to reclassify the device will be under 
the authority of section 513(e) of the act.
    A request for a change in the classification of these devices is to 
be in the form of a reclassification petition containing the 
information required by Sec. 860.123 (21 CFR 860.123), including new 
information relevant to the classification of the device, and shall, 
under section 515(b)(2)(B) of the act, be submitted by September 22, 
1995.
    The agency advises that, to ensure timely filing of any such 
petition, any request should be submitted to the Dockets Management 
Branch (address above) and not to the address provided in 
Sec. 860.123(b)(1). If a timely request for a change in the 
classification of these devices is submitted, the agency will, by 
November 6, 1995, after consultation with the appropriate FDA advisory 
committee and by an order published in the Federal Register, either 
deny the request or give notice of its intent to initiate a change in 
the classification of the device in accordance with section 513(e) of 
the act and Sec. 860.130 (21 CFR 860.130) of the regulations.

V. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because FDA believes that there is little or no 
interest in marketing these devices, the agency certifies that the 
proposed rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

VII. References

    The following information has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
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[[Page 46735]]

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of Perinatal Medicine, Prague, August 1974; edited by Stembera, Z. 
K., K. Pollacek, V. Sabata, and G. Thieme, Stuttgart, Avicenum, 
Prague, 1975:44-48.
    39. Peltzman, P., P. J. Goldstein, and R. Battagin, ``Optical 
Analysis of the Fetal Electroencephalogram,'' Journal of Obstetrics 
and Gynecology, 116(7):957-962, 1973.
    40. Rosen, M. G., J. J. Scibetta, and C. J. Hochberg, ``Fetal 
Electroencephalograph: IV. The FEEG During Spontaneous and Forceps 
Births,'' Obstetrics and Gynecology, 42(2):283-289, 1973.
    41. Borgstedt, A. D. et al., ``Fetal Electroencephalography,'' 
American Journal of Diseased Children, 129:35-38, January 1975.
    42. Ng, A. Y. H., ``Use of the Vibro Dilator in Outpatient 
Termination of Pregnancy,'' Australia and New Zealand Journal of 
Obstetrics and Gynecology, 13:228-230, 1973.
    43. Manabe, Y., and A. Nakajima, ``Laminaria Metreurynter Method 
of Midterm Abortion in Japan,'' Obstetrics and Gynecology, 40:612-
615, 1972.
    44. Manabe, Y. et al., ``Uterine Contractility and Placental 
Histology in Abortion by Laminaria and Metreurynter,'' Obstetrics 
and Gynecology, 41:753-759, 1973.
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and Treatment,'' Lange Medical Publications, Los Altos, CA, pp. 840-
841, 1976.
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Evaluation of a 

[[Page 46736]]
Mechanical Finger Prosthesis,'' in ``Joint Replacement in the Upper 
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Surgery, 57A:1004-1005, 1975.
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Joint Surgery, 58A:483-487, 1976.
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4:137-163, 1973.
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The Hand, 3:55-61, 1971.
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Finger Joints: Rationale, Technique and Results of Treatment,'' 
Journal of Bone and Joint Surgery, 54A:435-455, 1972.
    81. Swanson, A. B., ``Flexible Implant Arthroplasty in the 
Hand,'' Clinical and Plastic Surgery, 3:141-157, 1976.
    82. Hagert, C. G. et al., ``Metacarpophalangeal Joint 
Implants,'' Scandinavian Journal of Plastic and Reconstructive 
Surgery, 19:147-157, 1975.
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the Metacarpophalangeal Joints in Rheumatoid Arthritis,'' Journal of 
Bone and Joint Surgery, 57A:484-489, 1975.
    84. Ferlic, D. C., M. L. Clayton, and M. Holloway, 
``Complications of Silicone Implant Surgery in the 
Metacarpophalangeal Joint,''Journal of Bone and Joint Surgery, 
57A:991-994, 1975.
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Body Reaction to Silicone Rubber, Complication of a Finger Joint 
Implant,'' Clinical Orthopaedics and Related Research, 231-232.
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Scandinavian Journal of Plastic and Reconstructive Surgery, 9:216-
226, 1975.
    87. Weightman, S. S. et al., ``Environmental Fatigue Testing of 
Silastic Joint Prostheses,'' Journal of Biomedical Materials 
Research, Symposium, 3:15-24, 1972.
    88. Swanson, A. B., and J. H. Herndon, ``Flexible (Silicone) 
Implant Arthroplasty of the Metacarpophalangeal Joint of the 
Thumb,'' Journal of Bone and Joint Surgery, 59A:362-368, 1977.
    89. Swanson, A. B., ``Implant Resection Arthroplasty of the 
Proximal Interphalangeal Joint,'' Orthopedic Clinics of North 
America, 4(4):1007-1209, 1973.
    90. Braun, R. M., and J. Chandler, ``Quantitative Results 
Following Implant Arthroplasty of the Proximal Finger Joints in the 
Arthritic Hand,'' Clinical Orthopaedics and Related Research, 
83:135-143, 1972.
    91. Sivash, K. M., ``The Development of a Total Metal Prosthesis 
for the Hip Joint from a Partial Joint Replacement,'' Reconstructive 
Surgery and Traumatology, 11:53-62, 1969.
    92. McKellop, H. A. et al., ``Wear Properties of Sialon Ceramics 
and Delrin 150 Homopolymer Under Physiological Conditions,'' 
Transaction of the 4th Annual Meeting of the Society for 
Biomaterials, April 29-May 2, 1978.
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Prostheses--A Review,'' ``Corrosion and Degradation of Implant 
Material, ASTM STP684,'' American Society for Testing Materials, pp. 
41-60, 1978.
    94. Insall, J. N. et al., ``A Comparison of 4 Models of Total 
Knee Replacement Prostheses,'' Journal of Bone and Joint Surgery, 
58A:754-765, September 1976.
    95. Deburge, A., ``GUEPAR Hinge Prosthesis,'' Clinical 
Orthopedics, 120:47-53, October 1976.
    96. Engelbrecht, E. et al., ``Statistics of Total Knee 
Replacement: Partial and Total Knee Replacement,'' Clinical 
Orthopedics, 120:54-64, October 1976.
    97. Freeman, P. A., ``Walldius Arthroplasty,'' Clinical 
Orthopedics, 94:85-91, July-August 1973.
    98. Phillips, H., and J. G. Taylor, ``The Walldius Hinge 
Arthroplasty,'' Journal of Bone and Joint Surgery, 57B:51-62, 1975.
    99. Habermann, E. T., S. D. Deutsch, and G. D. Rovere, ``Knee 
Arthroplasty with the Use of the Walldius Total Knee Prosthesis,'' 
Clinical Orthopedics, 94:72-84, July-August 1973.
    100. Wilson, F. C., and G. L. Venters, ``Results of Knee 
Replacement with the Walldius Prosthesis,'' Clinical Orthopedics, 
20:39-46, October 1976.
    101. Blundell-Jones, G., ``Total Knee Replacement--The Walldius 
Hinge,'' Clinical Orthopedics, 94:50:57, July-August 1973.
    102. Bain, A. M., ``Replacement of the Knee Joint with the 
Walldius Prosthesis Using Cement Fixation,'' Clinical Orthopedics, 
94:65-71, July-August 1973.
    103. Brady, T. A., and J. N. Garber, ``Knee Joint Replacement 
Using Shiers Knee Hinge,'' Journal of Bone and Joint Surgery, 
56A:1610-1614, December 1974.
    104. Watson, J. R., H. Wood, and R. C. J. Hill, ``The Shiers 
Arthroplasty of the Knee,'' Journal of Bone and Joint Surgery, 
58B:300-304, August 1976.
    105. Kettlekamp, D. B., ``Total Joint Replacement,'' 
``Proceedings of the Workshop: Mechanical Failure of Total Joint 
Replacement, Atlanta, June 1978,'' The Sterring Committee, American 
Academy of Orthopaedic Surgeons, Chicago, 1978.
    106. Chand, K., ``The Knee Joint in Rheumatoid Arthritis III. 
Treatment by Hinged Total Knee Prosthetic Replacement,'' 
International Surgery, 59:600-607, November-December 1974.
    107. Deburge, A., J. H. Aubriot, and J. P. Genet, ``Current 
Status of a Hinge Prosthesis (GUEPAR),'' Clinical Orthopedics and 
Related Research, 145:91-93, November-December 1979.
    108. Arden, G. P., and B. A. Kamdar, ``Complications of 
Arthroplasty of the Knee,'' in ``Total Knee Replacement,'' chaired 
by L. G. P. Shiers, Mechanical Engineering Publications, Ltd., 
London, pp. 118-122, 1975.
    109. Kaushal, S. P. et al., ``Complications Following Total Knee 
Replacements,'' Clinical Orthopedics and Related Research, 121:181-
187, November-December 1976.
    110. Van Camp, D. H., H. W. Croon, and J. Lindwer, ``Influence 
of Cyclic Loading on 

[[Page 46737]]
Mechanical Loosening of Hinged Knee Prostheses,'' Engineering in 
Medicine, 4:235-239, 1978.
    111. Walker, P. S., ``Human Joints and Their Artificial 
Replacements,'' Charles C. Thomas, publisher, Springfield, IL, p. 
321, 1977.
    112. Wagner, J., and R. Bourgois, ``Biomedical Study of the 
Hinged Knee Prosthesis,'' Clinical Orthopedics and Related Research, 
102:188-193, July-August 1974.
    113. Swanson, S. A. V., M. A. R. Freeman, and J. C. Health, 
``Laboratory Tests on Total Joint Replacement Prostheses,'' Journal 
of Bone and Joint Surgery, 55B:759-773, November 1973.
    114. Brodersen, M. P. et al., ``Arthrodesis of the Knee 
Following Failed Total Knee Arthroplasty,'' Journal of Bone and 
Joint Surgery, 61A:181-185, March 1979.
    115. Hanslik, L., ``Das patellofemorale Gleitlagerbeim total 
kniegelenkersatz. Vorlaeufige Mitteilung ueber die implantation 
einer modifizierten McKeever-Endoprothese in Kombination mit der 
Alloarthroplastik nach Young,'' Zeitschrift fuer Orthopaedic and 
Ihre Gremzgebicte, 109:435-440, 1971.
    116. Young, H. H., ``Use of Hinged Vitallium Prosthesis for 
Arthroplasty of the Knee. A Preliminary Report,'' Journal of Bone 
and Joint Surgery, 45A:1627-1641, 1963.
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Knee Prosthesis: A Case Report With a Followup of 3.5 years and 
Histological and Metallurgical Data,'' Journal of Bone and Joint 
Surgery, 50A:355-364, 1968.
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Synovectomy and Arthroplasty in Rheumatoid Arthritis,'' edited by 
Chapchal, G., G. Thieme, Verlag, Stuttgart, pp. 85-86, 1967.
    119. Friedebold, G., and H. Radloff, ``Alloarthroplasties of the 
Knee Joint. Indications and Results,'' Reconstructive Surgery and 
Traumatology, 12:181-196, 1971.
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Type Hinged Vitallium Prosthesis,'' Reconstructive Surgery and 
Traumatology, 12:176-180, 1971.
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Using the Young Hinged Prosthesis Combined with a Modification on 
the McKeever Patella Prosthesis,'' Clinical Orthopedics, 94:115-121, 
1973.
    122. Fox, K. W., ``Geometric Total Knee Arthroplasty: Local 
Complications,'' Texas Medicine, 72:92-97, 1976.
    123. Platt, G., and C. Pepler, ``Mould Arthroplasty of the Knee. 
A Ten-Year Followup Study,'' Journal of Bone and Joint Surgery, 
51B:76-87, 1969.
    124. Aufranc, O. E., and W. N. Jones, ``Mold Arthroplasty of the 
Knee,'' Journal of Bone and Joint Surgery, 40A:1431, 1958.
    125. Jones, W. N., ``Mold Arthroplasty of the Knee Joint,'' 
Clinical Orthopedics, 66:82-89, 1969.
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Arthroplasty,'' Clinical Orthopedics, 120:7-10, 1976.
    127. Kitridou, R. C. et al., ``Recurrent Hemarthrosis After 
Prosthetic Knee Arthroplasty,'' Arthritis and Rheumatism, 12(5):520-
528, 1969.
    128. Turner, R. H., and O. E. Aufranc, ``Femoral Stem 
Replacement Arthroplasty of the Knee,'' Surgical Clinics of North 
America, 49(4):917-927, 1969.
    129. Friedebold, G., and H. Radloff, ``Alloarthroplasties of the 
Knee Joint. Indications and Results,'' Reconstructive Surgery and 
Traumatology, 12:181-196, 1971.
    130. Yeoman, P. M., ``Arthroplasty of the Knee: A Comparative 
Study of Platt's Mold and McKee Arthroplasties,'' Journal of Bone 
and Joint Surgery, 53B(1):150, 1971.
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Tibial and/or Femoral Metallic Implants in Rheumatoid Arthritis,'' 
Arthritis and Rheumatism, 15:1-15, 1972.
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Endoprosthesis of the Knee Joint Preserving the Ligaments,'' Acta 
Orthopaedica Belgica, 39:210-215, 1973.
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``Workshop on Fundamental Studies for Internal Structural 
Prostheses,'' chaired by F. W. Clippinger, Jr., National Academy of 
Sciences, Washington, DC pp., 19-23, 1973.
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in 150 Rheumatoid Knees,'' Acta Orthopaedica Belgica, 39:138-147, 
1973.
    135. Wilde, A. H. et al., ``Current Use of Geometric Knee 
Replacement Arthroplasty,'' Orthopedic Review, 3(3):25-31, 1974.
    136. Romero, R. L., and E. M. Burgess, ``Total Shoulder 
Replacement,'' Journal of Bone and Joint Surgery, 57A:1033, 1975.
    137. Fenlin, J. M., Jr., ``Total Shoulder Prosthesis,'' Journal 
of Bone and Joint Surgery, 58A:735, 1976.
    138. Fenlin, J. M., Jr., ``Total Glenohumeral Joint 
Replacement,'' Orthopedic Clinics of North America, 6:565-583, 1975.
    139. Linscheid, R. L., and R. H. Cofield, ``Total Shoulder 
Arthroplasty: Experimental but Promising,'' Geriatrics, 64-69, April 
1976.
    140. Cofield, R. H., ``Status of Total Shoulder Arthroplasty,'' 
Archives of Surgery, 12:1088-1091, 1971.
    141. Buechel, F. F., M. J. Pappas, and A. F. DePalma, 
``'Floating Socket' Total Shoulder Replacement: Anatomical, 
Biomechanical and Surgical Rationale,'' Journal of Biomedical 
Materials Research, 12:89-144, 1978.
    142. Cofield, R. H., and R. N. Stauffer, ``The Bickel 
Glenohumeral Arthroplasty,'' in ``Joint Replacement in the Upper 
Limb: Institution of Mechanical Engineers, 1977-1985,'' Mechanical 
Engineering Publications Ltd., Great Britain, pp. 15-20, 1977.
    143. Cofield, R. H., ``Total Shoulder Arthroplasty: The Current 
State of Development,'' in ``DHEW/RSA Workshop on Internal Joint 
Replacement,'' edited by C. L. Compere and J. L. Lewis, Chicago, pp. 
33-37, 1977.
    144. Gschwend, N., H. Scheier, and A. Bahler, ``GSB Elbow, 
Wrist, MP and PIP Joints,'' in ``Proceedings of Joint Replacement in 
the Upper Limb Conference,'' sponsored by the Institute of 
Mechanical Engineering, April 18-20, pp. 107-116, 1977.
    145. Peizer, E., ``Special Programs: VA Prosthetics Center 
Research, Development, and Evaluation Program,'' Bulletin of 
Prosthetics Research, 10-22:469-477, Fall 1974.
    146. ``Evaluation of the Ortho-Walk Type B Pneumatic Orthosis on 
Thirty-Seven Paraplegic Patients,'' Report by the Committee on 
Prosthetics Research and Development/Committee on Prosthetic-
Orthotic Education, National Academy of Sciences, Washington, DC, 
1976. Supported by the Veterans' Administration and the Social 
Rehabilitation Service, Department of Health, Education, and 
Welfare.

List of Subjects

21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

21 CFR Parts 868, 870, 872, 876, 880, 882, 884, 888, and 890

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 864, 868, 870, 872, 876, 880, 882, 884, 888, 
and 890 be amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    1. The authority citation for 21 CFR part 864 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. Section 864.5220 is amended by revising paragraph (c) to read as 
follows:


Sec. 864.5220  Automated differential cell counter.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before (date 90 days after date of 
publication of the final rule based on this proposed rule). For any 
automated differential cell counter described in paragraph (b)(2) of 
this section that was in commercial distribution before May 28, 1976, 
or that has, on or before (date 90 days after date of publication of 
the final rule based on this proposed rule), been found to be 
substantially equivalent to an automated differential cell counter 
described in paragraph (b)(2) of this section that was in commercial 
distribution before May 28, 1976. Any other automated differential cell 
counter described in paragraph (b)(2) of this section shall have an 
approved PMA or declared 

[[Page 46738]]
completed PDP in effect before being placed in commercial distribution.

PART 868--ANESTHESIOLOGY DEVICES

    3. The authority citation for 21 CFR part 868 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    4. Section 868.5400 is amended by revising paragraph (c) to read as 
follows:


Sec. 868.5400  Electroanesthesia apparatus.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before (date 90 days after date of 
publication of the final rule based on this proposed rule) for any 
electroanesthesia apparatus that was in commercial distribution before 
May 28, 1976, or that has, on or before (date 90 days after date of 
publication of the final rule), been found to be substantially 
equivalent to a electroanesthesia apparatus that was in commercial 
distribution before May 28, 1976. Any other electroanesthesia apparatus 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.

PART--870 CARDIOVASCULAR DEVICES

    5. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    6. Section 870.1350 is amended by revising paragraph (c) to read as 
follows:


Sec. 870.1350  Catheter balloon repair kit.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before (date 90 days after date of 
publication of the final rule). For any catheter balloon repair kit 
that was in commercial distribution before May 28, 1976, or that has, 
on or before (date 90 days after date of publication of the final 
rule), been found to be substantially equivalent to a catheter balloon 
repair kit that was in commercial distribution before May 28, 1976. Any 
other catheter balloon repair kit shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.
    7. Section 870.1360 is amended by revising paragraph (c) to read as 
follows:

Sec. 870.1360  Trace microsphere.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before (date 90 days after date of 
publication of the final rule). For any trace microsphere that was in 
commercial distribution before May 28, 1976, or that has, on or before 
(date 90 days after date of publication of the final rule), been found 
to be substantially equivalent to a trace microsphere that was in 
commercial distribution before May 28, 1976. Any other trace 
microsphere shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.
    8. Section 870.3850 is amended by revising paragraph (c) to read as 
follows:

Sec. 870.3850  Carotid sinus nerve stimulator.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any carotid sinus nerve stimulator 
that was in commercial distribution before May 28, 1976, or that has, 
on or before (date 90 days after date of publication of the final 
rule), been found to be substantially equivalent to a carotid sinus 
nerve stimulator that was in commercial distribution before May 28, 
1976. Any other carotid sinus nerve stimulator shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.
    9. Section 870.5300 is amended by revising paragraph (c) to read as 
follows:

Sec. 870.5300  DC-defibrillator (including paddles).

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule). For any DC-defibrillator (including 
paddles) described in paragraph (b)(1) of this section that was in 
commercial distribution before May 28, 1976, or that has, on or before 
(date 90 days after date of publication of the final rule), been found 
to be substantially equivalent to a DC-defibrillator (including 
paddles) described in paragraph (b)(1) of this section that was in 
commercial distribution before May 28, 1976. Any other DC-defibrillator 
(including paddles) described in paragraph (b)(1) of this section shall 
have an approved PMA or declared completed PDP in effect before being 
placed in commercial distribution.

PART 872--DENTAL DEVICES

    10. The authority citation for 21 CFR part 872 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    11. Section 872.3400 is amended by revising paragraph (c) to read 
as follows:

Sec. 872.3400  Karaya and sodium borate with or without acacia denture 
adhesive.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any karaya and sodium borate with or 
without acacia denture adhesive that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication of the final rule), been found to be substantially 
equivalent to a karaya and sodium borate with or without acacia denture 
adhesive that was in commercial distribution before May 28, 1976. Any 
other karaya and sodium borate with or without acacia denture adhesive 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.
    12. Section 872.3420 is amended by revising paragraph (c) to read 
as follows:

Sec. 872.3420  Carboxymethylcellulose sodium and cationic 
polyacrylamide polymer denture adhesive.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any carboxymethylcellulose sodium 
and cationic polyacrylamide polymer denture adhesive that was in 
commercial distribution before May 28, 1976, or that has, on or before 
(date 90 days after date of publication of the final rule), been found 
to be substantially equivalent to a carboxymethylcellulose sodium and 
cationic polyacrylamide polymer denture adhesive that was in 

[[Page 46739]]
commercial distribution before May 28, 1976. Any other 
carboxymethylcellulose sodium and cationic polyacrylamide polymer 
denture adhesive shall have an approved PMA or a declared completed PDP 
in effect before being placed in commercial distribution.
    13. Section 872.3480 is amended by revising paragraph (c) to read 
as follows:

Sec. 872.3480  Polyacrylamide polymer (modified cationic) denture 
adhesive.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any polyacrylamide polymer (modified 
cationic) denture adhesive that was in commercial distribution before 
May 28, 1976, or that has, on or before (date 90 days after date of 
publication of the final rule), been found to be substantially 
equivalent to a polyacrylamide polymer (modified cationic) denture 
adhesive that was in commercial distribution before May 28, 1976. Any 
other polyacrylamide polymer (modified cationic) denture adhesive shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.
    14. Section 872.3500 is amended by revising paragraph (c) to read 
as follows:

Sec. 872.3500  Polyvinylmethylether maleic anhydride (PVM-MA), acid 
copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any polyvinylmethylether maleic 
anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium 
(NACMC) denture adhesive that was in commercial distribution before May 
28, 1976, or that has, on or before (date 90 days after date of 
publication of the final rule), been found to be substantially 
equivalent to a polyvinylmethylether maleic anhydride (PVM-MA), acid 
copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive 
that was in commercial distribution before May 28, 1976. Any other 
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and 
carboxymethylcellulose sodium (NACMC) denture adhesive shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.
    15. Section 872.3560 is amended by revising paragraph (c) to read 
as follows:

Sec. 872.3560  OTC denture reliner.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any OTC denture reliner that was in 
commercial distribution before May 28, 1976, or that has, on or before 
(date 90 days after date of publication of the final rule), been found 
to be substantially equivalent to an OTC denture reliner that was in 
commercial distribution before May 28, 1976. Any other OTC denture 
reliner shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.
    16. Section 872.3820 is amended by revising paragraph (c) to read 
as follows:

Sec. 872.3820  Root canal filling resin.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any root canal filling resin 
described in paragraph (b)(2) of this section that was in commercial 
distribution before May 28, 1976, or that has, on or before (date 90 
days after date of publication of the final rule), been found to be 
substantially equivalent to a root canal filling resin described in 
paragraph (b)(2) of this section that was in commercial distribution 
before May 28, 1976. Any other root canal filling resin shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    17. The authority citation for 21 CFR part 876 is revised to read 
as follows:

    Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 
360e, 360j, 360l, 371).

    18. Section 876.5220 is amended by revising paragraph (c) to read 
as follows:


Sec. 876.5220  Colonic irrigation system.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any colonic irrigation system 
described in paragraph (b)(2) of this section that was in commercial 
distribution before May 28, 1976, or that has, on or before (date 90 
days after date of publication of the final rule), been found to be 
substantially equivalent to a colonic irrigation system described in 
paragraph (b)(2) of this section that was in commercial distribution 
before May 28, 1976. Any other colonic irrigation system shall have an 
approved PMA in effect before being placed in commercial distribution.
    19. Section 876.5270 is amended by revising paragraph (c) to read 
as follows:

Sec. 876.5270  Implanted electrical urinary continence device.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any implanted electrical urinary 
continence device that was in commercial distribution before May 28, 
1976, or that has, on or before (date 90 days after date of publication 
of the final rule), been found to be substantially equivalent to an 
implanted electrical urinary continence device that was in commercial 
distribution before May 28, 1976. Any other implanted electrical 
urinary continence device shall have an approved PMA or a declared 
completed PDP in effect before being place in commercial distribution.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    20. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    21. Section 880.5760 is amended by revising paragraph (c) to read 
as follows:


Sec. 880.5760  Chemical cold pack snakebite kit.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any chemical cold pack snakebite kit 
that was in commercial distribution before May 28, 1976, or that has, 
on or before (date 90 days after date 

[[Page 46740]]
of publication of the final rule), been found to be substantially 
equivalent to a chemical cold pack snakebite kit that was in commercial 
distribution before May 28, 1976. Any other chemical cold pack 
snakebite kit shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.

PART 882--NEUROLOGICAL DEVICES

    22. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    23. Section 882.1825 is amended by revising paragraph (c) to read 
as follows:


Sec. 882.1825  Rheoencephalograph.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any rheoencephalograph that was in 
commercial distribution before May 28, 1976, or that has, on or before 
(date 90 days after date of publication of the final rule), been found 
to be substantially equivalent to a rheoencephalograph that was in 
commercial distribution before May 28, 1976. Any other 
rheoencephalograph shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.
    24. Section 882.5150 is amended by revising paragraph (c) to read 
as follows:

Sec. 882.5150  Intravascular occluding catheter.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any intravascular occluding catheter 
that was in commercial distribution before May 28, 1976, or that has, 
on or before (date 90 days after date of publication of the final 
rule), been found to be substantially equivalent to a intravascular 
occluding catheter that was in commercial distribution before May 28, 
1976. Any other intravascular occluding catheter shall have an approved 
PMA or a declared completed PDP in effect before being place in 
commercial distribution.
    25. Section 882.5850 is amended by revising paragraph (c) to read 
as follows:

Sec. 882.5850  Implanted spinal cord stimulator for bladder evacuation.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any implanted spinal cord stimulator 
for bladder evacuation that was in commercial distribution before May 
28, 1976, or that has, on or before (date 90 days after date of 
publication of the final rule), been found to be substantially 
equivalent to an implanted spinal cord stimulator for bladder 
evacuation that was in commercial distribution before May 28, 1976. Any 
other implanted spinal cord stimulator for bladder evacuation shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    26. The authority citation for 21 CFR part 884 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    27. Section 884.2050 is amended by revising paragraph (c) to read 
as follows:


Sec. 884.2050  Obstetric data analyzer.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any obstetric data analyzer that was 
in commercial distribution before May 28, 1976, or that has, on or 
before (date 90 days after date of publication of the final rule), been 
found to be substantially equivalent to an obstetrical data analyzer 
that was in commercial distribution before May 28, 1976. Any other 
obstetric data analyzer shall have an approved PMA or a declared 
completed PDP in effect before being place in commercial distribution.
    28. Section 884.2620 is amended by revising paragraph (c) to read 
as follows:

Sec. 884.2620  Fetal electroencephalographic monitor.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any fetal electroencephalographic 
monitor that was in commercial distribution before May 28, 1976, or 
that has, on or before (date 90 days after date of publication of the 
final rule), been found to be substantially equivalent to a fetal 
electroencephalographic monitor in commercial distribution before May 
28, 1976. Any other fetal electroencephalographic monitor shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.
    29. Section 884.2685 is amended by revising paragraph (c) to read 
as follows:

Sec. 884.2685  Fetal scalp clip electrode and applicator.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any fetal scalp clip electrode and 
applicator that was in commercial distribution before May 28, 1976, or 
that has, on or before (date 90 days after date of publication of the 
final rule), been found to be substantially equivalent to a fetal scalp 
clip electrode and applicator that was in commercial distribution 
before May 28, 1976. Any other fetal scalp clip electrode and 
applicator shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.
    30. Section 884.4250 is amended by revising paragraph (c) to read 
as follows:

Sec. 884.4250  Expandable cervical dilator.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any expandable cervical dilator that 
was in commercial distribution before May 28, 1976, or that has, on or 
before (date 90 days after date of publication of the final rule), been 
found to be substantially equivalent to an expandable cervical dilator 
that was in commercial distribution before May 28, 1976. Any other 
expandable cervical dilator shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.
    31. Section 884.4270 is amended by revising paragraph (c) to read 
as follows:


[[Page 46741]]



Sec. 884.4270  Vibratory cervical dilators.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any vibratory cervical dilator that 
was in commercial distribution before May 28, 1976, or that has, on or 
before (date 90 days after date of publication of the final rule), been 
found to be substantially equivalent to a vibratory cervical dilator 
that was in commercial distribution before May 28, 1976. Any other 
vibratory cervical dilator shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.
    32. Section 884.5050 is amended by revising paragraph (c) to read 
as follows:

Sec. 884.5050  Metreurynter-balloon abortion system.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any metreurynter-balloon abortion 
system that was in commercial distribution before May 28, 1976, or that 
has, on or before (date 90 days after date of publication of the final 
rule), been found to be substantially equivalent to a metreurynter-
balloon abortion system that was in commercial distribution before May 
28, 1976. Any other metreurynter-balloon abortion system shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.
    33. Section 884.5225 is amended by revising paragraph (c) to read 
as follows:

Sec. 884.5225  Abdominal decompression chamber.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any abdominal decompression chamber 
that was in commercial distribution before May 28, 1976, or that has, 
on or before (date 90 days after date of publication of the final 
rule), been found to be substantially equivalent to an abdominal 
decompression chamber that was in commercial distribution before May 
28, 1976. Any other abdominal decompression chamber shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

PART 888--ORTHOPEDIC DEVICES

    34. The authority citation for 21 CFR part 888 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    35. Section 888.3120 is amended by revising paragraph (c) to read 
as follows:


Sec. 888.3120  Ankle joint metal/polymer non-constrained cemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any ankle joint metal/polymer non-
constrained cemented prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication of the final rule), been found to be substantially 
equivalent to a ankle joint metal/polymer non-constrained cemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other ankle joint metal/polymer non-constrained cemented prosthesis 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.
    36. Section 888.3180 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3180  Elbow joint humeral (hemi-elbow) metallic uncemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any elbow joint humeral (hemi-elbow) 
metallic uncemented prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication of the final rule), been found to be substantially 
equivalent to a elbow joint humeral (hemi-elbow) metallic uncemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other elbow joint humeral (hemi-elbow) metallic uncemented prosthesis 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.
    37. Section 888.3200 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3200  Finger joint metal/metal constrained uncemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule), for any finger joint metal/metal 
constrained uncemented prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication of the final rule), been found to be substantially 
equivalent to a finger joint metal/metal constrained uncemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other finger joint metal/metal constrained uncemented prosthesis shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.
    38. Section 888.3210 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3210  Finger joint metal/metal constrained cemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any finger joint metal/metal 
constrained cemented prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication of the final rule), been found to be substantially 
equivalent to a finger joint metal/metal constrained cemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other finger joint metal/metal constrained cemented prosthesis shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.
    39. Section 888.3220 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3220  Finger joint metal/polymer constrained cemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 

[[Page 46742]]
days after date of publication of the final rule) for any finger joint 
metal/polymer constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976, or that has, on or before (date 90 
days after date of publication of the final rule), been found to be 
substantially equivalent to a finger joint metal/polymer constrained 
cemented prosthesis that was in commercial distribution before May 28, 
1976. Any other finger joint metal/polymer constrained cemented 
prosthesis shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.
    40. Section 888.3300 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3300  Hip joint metal constrained cemented or uncemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any hip joint metal constrained 
cemented or uncemented prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication of the final rule), been found to be substantially 
equivalent to a hip joint metal constrained cemented or uncemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other hip joint metal constrained cemented or uncemented prosthesis 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.
    41. Section 888.3310 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3310  Hip joint metal/polymer constrained cemented or 
uncemented prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any hip joint metal/polymer 
constrained cemented or uncemented prosthesis that was in commercial 
distribution before May 28, 1976, or that has, on or before (date 90 
days after date of publication of the final rule), been found to be 
substantially equivalent to a hip joint metal/polymer constrained 
cemented or uncemented prosthesis that was in commercial distribution 
before May 28, 1976. Any other hip joint metal/polymer constrained 
cemented or uncemented prosthesis shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.
    42. Section 888.3370 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3370  Hip joint (hemi-hip) acetabular metal cemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any hip joint (hemi-hip) acetabular 
metal cemented prosthesis that was in commercial distribution before 
May 28, 1976, or that has, on or before (date 90 days after date of 
publication of the final rule), been found to be substantially 
equivalent to a hip joint (hemi-hip) acetabular metal cemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other hip joint metal (hemi-hip) acetabular metal cemented prosthesis 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.
    43. Section 888.3380 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3380  Hip joint femoral (hemi-hip) trunnion-bearing metal/
polyacetal cemented prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any hip joint femoral (hemi-hip) 
trunnion-bearing metal/polyacetal cemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
(date 90 days after date of publication of the final rule), been found 
to be substantially equivalent to a hip joint femoral (hemi-hip) 
trunnion-bearing metal/polyacetal cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other hip joint 
femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented 
prosthesis shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.
    44. Section 888.3480 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3480  Knee joint femorotibial metallic constrained cemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any knee joint femorotibial metallic 
constrained cemented prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication in the Federal Register of the final rule based on this 
proposed rule), been found to be substantially equivalent to a knee 
joint femorotibial metallic constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other knee joint 
femorotibial metallic constrained cemented prosthesis shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.
    45. Section 888.3540 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3540  Knee joint patellofemoral polymer/metal semi-constrained 
cemented prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any knee joint patellofemoral 
polymer/metal semi-constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
(date 90 days after date of publication of the final rule), been found 
to be substantially equivalent to a knee joint patellofemoral polymer/
metal semi-constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976. Any other knee joint patellofemoral 
polymer/metal semi-constrained cemented prosthesis shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.
    46. Section 888.3550 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3550  Knee joint patellofemorotibial polymer/metal/metal 
constrained cemented prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any knee joint patellofemorotibial 
polymer/metal/metal constrained cemented prosthesis 

[[Page 46743]]
that was in commercial distribution before May 28, 1976, or that has, 
on or before (date 90 days after date of publication of the final 
rule), been found to be substantially equivalent to a knee joint 
patellofemorotibial polymer/metal/metal constrained cemented prosthesis 
that was in commercial distribution before May 28, 1976. Any other knee 
joint patellofemorotibial polymer/metal/metal constrained cemented 
prosthesis shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.
    47. Section 888.3570 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3570  Knee joint femoral (hemi-knee) metallic uncemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any knee joint femoral (hemi-knee) 
metallic uncemented prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before (date 90 days after date 
of publication of the final rule), been found to be substantially 
equivalent to a knee joint femoral (hemi-knee) metallic uncemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other knee joint femoral (hemi-knee) metallic uncemented prosthesis 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.
    48. Section 888.3580 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3580  Knee joint patellar (hemi-knee) metallic resurfacing 
uncemented prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any knee joint patellar (hemi-knee) 
metallic resurfacing uncemented prosthesis described in paragraph 
(b)(2) of this section that was in commercial distribution before May 
28, 1976, or that has on or before (date 90 days after date of 
publication of the final rule), been found to be substantially 
equivalent to a knee joint patellar (hemi-knee) metallic resurfacing 
uncemented prosthesis that was in commercial distribution before May 
28, 1976. Any other knee joint patellar (hemi-knee) metallic 
resurfacing uncemented prosthesis shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.
    49. Section 888.3640 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3640  Shoulder joint metal/metal or metal/polymer constrained 
cemented prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any shoulder joint metal/metal or 
metal/polymer constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976, or that has, on or before (date 90 
days after date of publication of the final rule), been found to be 
substantially equivalent to a shoulder joint metal/metal or metal/
polymer constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976. Any other shoulder joint metal/metal 
or metal/polymer constrained cemented prosthesis shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.
    50. Section 888.3680 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3680  Shoulder joint glenoid (hemi-shoulder) metallic cemented 
prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any shoulder joint glenoid (hemi-
shoulder) metallic cemented prosthesis that was in commercial 
distribution before May 28, 1976, or that has, on or before (date 90 
days after date of publication of the final rule), been found to be 
substantially equivalent to a shoulder joint glenoid (hemi-shoulder) 
metallic cemented prosthesis that was in commercial distribution before 
May 28, 1976. Any other shoulder joint glenoid (hemi-shoulder) metallic 
cemented prosthesis shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.
    51. Section 888.3790 is amended by revising paragraph (c) to read 
as follows:

Sec. 888.3790  Wrist joint metal constrained cemented prosthesis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any wrist joint metal constrained 
cemented prosthesis that was in commercial distribution before May 28, 
1976, or that has, on or before (date 90 days after date of publication 
of the final rule), been found to be substantially equivalent to a 
wrist joint metal constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other wrist joint 
metal constrained cemented prosthesis shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.

PART 890--PHYSICAL MEDICINE DEVICES

    52. The authority citation for 21 CFR part 890 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    53. Section 890.3610 is amended by revising paragraph (c) to read 
as follows:


Sec. 890.3610  Rigid pneumatic structure orthosis.

* * * * *
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before (date 90 days after date of 
publication of the final rule) for any rigid pneumatic structure 
orthosis that was in commercial distribution before May 28, 1976, or 
that has, on or before (date 90 days after date of publication of the 
final rule), been found to be substantially equivalent to a rigid 
pneumatic structure orthosis that was in commercial distribution before 
May 28, 1976. Any other rigid pneumatic structure orthosis shall have 
an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

    Dated: August 9, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-22027 Filed 9-6-95; 8:45 am]
BILLING CODE 4160-01-F