[Federal Register Volume 64, Number 103 (Friday, May 28, 1999)]
[Notices]
[Pages 29043-29046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97P-0354]


Orthopedic Devices; Reclassification of the Shoulder Joint Metal/
Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated 
Uncemented Prosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of panel recommendation.

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SUMMARY: The Food and Drug Administration (FDA) is announcing for 
public comment a recommendation of the Orthopedic and Rehabilitation 
Devices Panel (the Panel) to reclassify the shoulder joint metal/
polymer/metal nonconstrained or semi-constrained porous-coated 
uncemented prosthesis from class III into class II. The Panel made this 
recommendation after reviewing the reclassification petition submitted 
by the Orthopedic Surgical Manufacturers Association (OSMA) and other 
publicly available information. FDA is also announcing for public 
comment its tentative findings on the Panel's recommendations. After 
considering any public comments on the Panel's recommendations and 
FDA's tentative findings, FDA will approve or deny the reclassification 
petition by order in the form of a letter to the petitioner. FDA's 
decision on the reclassification petition will be announced in the 
Federal Register.

DATES: Written comments by August 26, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Theodore R. Stevens, Center for 
Devices and Radiological Health (HFZ-410), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2036.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 
amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the 
SMDA) (Pub. L. 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (Pub. L. 105-115) established a comprehensive 
system for the regulation of medical devices intended for human use. 
Section 513 of the act (21 U.S.C. 360c) established three categories 
(classes) of devices, depending on the regulatory controls needed to 
provide reasonable assurance of their safety and effectiveness. The 
three categories of devices are class I (general controls), class II 
(special controls), and class III (premarket approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, under section 513(i) of the act, 
to a predicate device that does not require premarket approval. The 
agency determines whether new devices are substantially equivalent to 
previously offered devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807 of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Reclassification of classified postamendments devices is governed 
by section 513(f)(2) of the act. This section provides that FDA may 
initiate the reclassification of a device classified into class III 
under section 513(f)(1) of the act, or the manufacturer or importer of 
a device may petition the Secretary of the Department of Health and 
Human

[[Page 29044]]

Services (the Secretary) for the issuance of an order classifying the 
device in class I or class II. FDA's regulations in Sec. 860.134 (21 
CFR 860.134) set forth the procedures for the filing and review of a 
petition for reclassification of such class III devices. In order to 
change the classification of the device, it is necessary that the 
proposed new class have sufficient regulatory controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use.
    Under section 513(f)(2)(B)(i) of the act, the Secretary may, for 
good cause shown, refer a petition to a device classification panel. 
The Panel shall make a recommendation to the Secretary respecting 
approval or denial of the petition. Any such recommendation shall 
contain: (1) A summary of the reasons for the recommendation, (2) a 
summary of the data upon which the recommendation is based, and (3) an 
identification of the risks to health (if any) presented by the device 
with respect to which the petition was filed.

II. Regulatory History of the Device

    The shoulder joint metal/polymer/metal nonconstrained or semi-
constrained porous-coated uncemented prosthesis intended to be 
implanted to replace the shoulder joint is a postamendment device 
classified into class III under section 513(f)(2) of the act. 
Therefore, the device cannot be placed in commercial distribution for 
implantation to replace the shoulder joint unless it is reclassified 
under section 513(f)(2), or subject to an approved premarket approval 
application (PMA) under section 515 of the act.
    This action is taken in accordance with section 513(f)(2) of the 
act and Sec. 860.134, based on information submitted in a petition for 
reclassification by OSMA received on July 23, 1997, requesting 
reclassification of the shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
from class III into class II (Ref. 1). Consistent with the act and the 
regulation, FDA referred the petition to the Panel for its 
recommendation on the requested changes in classification.

III. Device Description

    The following device description is based on the Panel's 
recommendations and the agency's review.
    A shoulder joint metal/polymer/metal nonconstrained or semi-
constrained porous-coated uncemented prosthesis is a device intended to 
be implanted to replace a shoulder joint. The device limits, with 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 humeral component made of alloys such as cobalt-
chromium-molybdenum (Co-Cr-Mo) and/or titanium-aluminum-vanadium (Ti-
6Al-4V) alloys, and a glenoid resurfacing component made of ultrahigh 
molecular weight polyethylene, or a combination of an articulating 
ultra-high molecular weight bearing surface fixed in a metal shell made 
of alloys such as Co-Cr-Mo and/or Ti-6Al-4V. The humeral component and 
glenoid backing have a substrate porous coating made of, in Co-Cr-Mo 
components, beads of the same alloy or commercially pure titanium 
powder, and in Ti-6Al-4V components, beads or fibers of commercially 
pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. 
The porous coating has a volume porosity between 30 to 70 percent, an 
average pore size between 100 to 1,000 microns, interconnecting 
porosity, and a porous coating thickness of 600 to 1,500 microns. This 
generic type of device is designed to achieve biological fixation to 
bone without the use of bone cement.

IV. Recommendation of the Panel

    At a public meeting on January 12 and 13, 1998, the Panel 
unanimously recommended that the shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
be reclassified from class III to class II. The Panel believed that 
class II with the proposed special controls (FDA Recognized Consensus 
Standards, Postmarket Surveillance, and FDA guidances) would reasonably 
ensure the safety and effectiveness of the device.

V. Risks to Health

    After considering the information in the petition, the Panel's 
deliberations, the published literature, and the Medical Device 
Reports, FDA has evaluated the risks to health associated with the use 
of the shoulder joint metal/polymer/metal nonconstrained or semi-
constrained porous-coated uncemented prosthesis. FDA now believes that 
the following are risks to health associated with use of the device: 
Infection, adverse tissue reaction, pain and/or loss of function, and 
revision. FDA notes that these risks to health are also associated with 
the use of the cemented versions of shoulder joint prostheses.

A. Infection

    Infection is a potential risk to health associated with all 
surgical procedures and implanted devices, and it occurs equally in 
patients implanted with cemented and uncemented shoulder joint 
prostheses (Ref. 1). The best defenses against infection are 
preventative measures, including selection of patients without known 
local and/or systematic infection, administration of perioperative 
antibiotics, implantation of a sterilized device, and strict adherence 
to sterile surgical technique.

B. Adverse Tissue Reaction

    Adverse tissue reaction is a potential risk to health associated 
with all implanted devices (Ref. 1). If the materials used in the 
manufacture of shoulder prostheses are not biocompatible, the patient 
could have an adverse tissue reaction. The shoulder prosthesis 
identified in this notice are made of implant materials with an 
established, long history of safe use. In addition, the 
biocompatiblility of porous-coated implant materials has been shown to 
be comparable to those of the ``as cast'' materials.

C. Pain and/or Loss of Function

    Pain and loss of shoulder function can occur with any shoulder 
arthroplasty. Some of the same kinds of device-related complications 
causing pain and loss of function are associated with implantation of 
both cemented and uncemented shoulder prostheses. These complications 
include: Early loosening due to inappropriate patient and/or device 
selection; inappropriate surgical technique and/or poor bone quality; 
some forms of metal and/or polyethylene wear which may cause osteolysis 
(dissolution of bone); and component disassembly, fracture, and/or 
failure. Dislocation and instability of the shoulder prosthesis may be 
due to either inappropriate surgical technique and/or component design 
or failure. However, other device-related complications resulting in 
pain and/or loss of function are directly or uniquely related to the 
porous coating(s) of uncemented shoulder prosthesis components. These 
complications include incomplete and/or slow biological ingrowth into 
the porous coating resulting in pain and dislocation/instability of the 
joint and delamination of the porous coating from the prosthesis 
components. Also, inadequate design and/or testing of the metal-backing 
of the glenoid component of uncemented shoulder prostheses may cause 
dislocation and instability which can result in pain and/or loss of 
function.

[[Page 29045]]

D. Revision

    The incidence of revision for uncemented shoulder prostheses is 
comparable to the revision rates of cemented total shoulder 
arthroplasty (Ref. 1). The major causes for revision of uncemented 
shoulder prostheses are failure of the metal-backed glenoid component 
or incomplete humeral fixation.

VI. Summary of the Reasons for the Recommendations

    After considering the data and information contained in the 
petition and provided by FDA, the open discussions during the Panel 
meeting, and their personal knowledge of and clinical experience with 
the device, the Panel gave the following reasons in support of its 
recommendations to reclassify the generic device, the shoulder joint 
metal/polymer/metal nonconstrained or semi-constrained porous-coated 
uncemented prosthesis intended to replace a shoulder joint from class 
III into class II. The Panel believes that the device should be 
reclassified into class II because special controls, in addition to 
general controls, would provide reasonable assurance of the safety and 
effectiveness of the device, and there is sufficient information to 
establish special controls to provide such assurance.

VII. Summary of Data Upon Which the Panel Recommendation Is Based

    In addition to the potential risks to health of the shoulder joint 
metal/polymer/metal nonconstrained or semi-constrained porous-coated 
uncemented prosthesis described in section V of this document, there is 
reasonable knowledge of the benefits of the device. Both cemented and 
uncemented shoulder prostheses provide decreased pain or cessation of 
pain and increased mobility and function, post-operatively resulting in 
an overall improved quality of patient life. A specific benefit of the 
uncemented shoulder prosthesis is the absence of risks associated with 
the use of bone cement (e.g., embolism and bone cement breakdown) and 
easier revision if revision should become indicated due to loosening.

VIII. Special Controls

    FDA believes that the special controls identified below in this 
document, in addition to general controls, are adequate to control the 
identified risks to health for this device. FDA agrees with the Panel 
that consensus standards and the FDA guidances are appropriate special 
controls to reasonably ensure the safety and effectiveness of the 
device. However, FDA disagrees with the Panel that postmarket 
surveillance is a necessary or appropriate special control for this 
device.
    In their deliberations, the Panel stated that it was important that 
adverse device outcomes should be reported to FDA. The Panel thought 
that adverse device outcomes should be tracked through postmarket 
surveillance. FDA agrees with the Panel that adverse device outcomes 
should be reported to FDA. However, FDA believes that another 
postmarket mechanism better addresses the Panel's concern that adverse 
device outcomes should be reported to FDA. FDA believes that the 
existing mandatory Medical Device Reporting system is the appropriate 
mechanism to report such adverse events. Therefore, postmarket 
surveillance is unnecessary to address the Panel's concerns, and to 
reasonably ensure the safety and effectiveness of the device.
    Based on the available information, FDA identified these 10 
voluntary standards from the American Society for Testing and Materials 
(ASTM) and 5 FDA guidance documents as the specific special controls to 
reasonably ensure the safety and effectiveness of the shoulder joint 
metal/polymer/metal nonconstrained or semi-constrained porous-coated 
uncemented prosthesis as follows:

A. ASTM Standards:

    1. ASTM F 67-95, ``Standard Specifications for Unalloyed Titanium 
for Surgical Implant Applications;''
    2. ASTM F 75-92, ``Standard Specification for Cast Cobalt-28 
Chromium-6 Molybdenum Alloy for Surgical Implant Applications;''
    3. ASTM F 136-96, ``Standard Specification for Wrought Titanium-6 
Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy (R56401)) for 
Surgical Implant Applications;''
    4. ASTM F 648-98, ``Standard Specification for Ultra-High-
Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical 
Implants;''
    5. ASTM F 1044-95, ``Standard Test Method for Shear Testing of 
Porous Metal Coatings;''
    6. ASTM F 1147-95, ``Standard Test Method for Tension Testing of 
Porous Metal Coatings;''
    7. ASTM F 1160-91, ``Standard Test Method for Constant Stress 
Amplitude Fatigue Testing of Porous Metal-Coated Metallic Materials;''
    8. ASTM F 1377-92, ``Standard Specification for Cobalt-28 Chromium-
6 Molybdenum Powder for Coating of Orthopedic Implants;''
    9. ASTM F 1378-97, ``Standard Specification for Shoulder 
Prostheses;'' and
    10. ASTM F 1580-95, ``Standard Specification for Titanium and 
Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical 
Implants.''
    The ASTM standards define implant material specifications and 
testing methods applicable to the shoulder joint metal/polymer/metal 
nonconstrained or unconstrained uncemented prosthesis. Adherence to 
these standards and comparison of the results from these standard test 
methods can control the risks to health of adverse tissue reaction, 
pain and/or loss of function, and revision by having the manufacturer 
use surgical implant quality materials and assuring that the device has 
acceptable performance through mechanical testing.
    Nine of the ASTM standards are FDA recognized consensus standards. 
FDA is now reviewing ASTM F1378-97, ``Standard Specification for 
Shoulder Prostheses'' for inclusion in the list of FDA recognized 
consensus standards. By the time this proposal is finalized as a final 
rule, ASTM F1378 is expected to be an FDA recognized consensus 
standard.
    ASTM standards may be obtained from ASTM Customer Services, 100 
Barr Harbor Dr., West Conshohocken, PA 19428 (Telephone 610-832-9585). 
ASTM has a site on the world wide web at ``http://www.astm.org/''.

B. FDA Guidances:

    1. ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement'' (Facts-on-
Demand # 827);
    2. ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components'' (Facts-on-Demand # 916);
    3. ``Draft Guidance Document for the Preparation of Premarket 
Notification (510(k)) Applications for Orthopedic Devices-The Basic 
Elements'' (Facts-on-Demand # 832);
    4. ``Use of International Standard ISO-10993, Biological Evaluation 
of Medical Devices Part I: Evaluation and Testing'' (Facts-on-Demand # 
164) ; and
    5. ``510(k) Sterility Review Guidance--and Revision of 11/18/94 
#K90-1'' (Facts-on-Demand # 361).
    FDA guidance documents provide guidance on how to meet general 
orthopedic device premarket notification (510(k)) requirements, 
including biocompatibility testing, sterility testing, mechanical 
performance testing, and physician and

[[Page 29046]]

patient labeling for the shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis. 
Use of the preclinical section of the FDA guidance documents can 
control the risks to health of adverse tissue reaction, infection, pain 
and/or loss of function, and revision by having manufacturers use 
surgical quality implant materials, adequately test and sterilize their 
devices, and provide adequate directions for use (and patient 
information).
    To receive a guidance via fax machine, telephone Center for Devices 
and Radiological Health's (CDRH) CDRH Facts-on-Demand system at 800-
399-0381, or 301-827-0111 from a touch-tone telephone. At the first 
voice prompt, press 1 to access the Division of Small Manufacturers 
Assistance Fax, at the second voice prompt, press 2, and then enter the 
document number followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request. The guidances are 
also available from the CDRH world wide web address at ``http://
www.fda.gov/cdrh''.

IX. FDA's Tentative Findings

    FDA believes that the shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
should be reclassified into class II because special controls, in 
addition to general controls, would provide reasonable assurance of the 
safety and effectiveness of the device, and there is sufficient 
information to establish special controls to provide such assurance.

X. References

    The following references have 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:
    1. Petition for Reclassification of Orthopaedic Shoulder 
Prostheses submitted by the Orthopedic Surgical Manufacturers 
Association, Warsaw, IN, received July 23, 1997.
    2. Transcript of the Orthopedic and Rehabilitation Devices Panel 
Meeting, January 12 and 13, 1998, vol. I, pp. 12 to 114.

XI. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
reclassification 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.

XII. Analysis of Impacts

    FDA has examined the impacts of the notice under Executive Order 
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended 
by subtitle D of the Small Business Regulatory Fairness Act of 1996 
(Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 104-4)). 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 reclassification action is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the reclassification action 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. Reclassification of the device from class III to 
class II will relieve manufacturers of the cost of complying with the 
premarket approval requirements in section 515 of the act. Because 
reclassification will reduce regulatory costs with respect to this 
device, it will impose no significant economic impact on any small 
entities, and it may permit small potential competitors to enter the 
marketplace by lowering their costs. The agency therefore certifies 
that this reclassification action, if finalized, will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this reclassification action will not impose costs of $100 
million or more on either the private sector or State, local, and 
tribal governments in the aggregate, and therefore a summary statement 
of analysis under section 202(a) of the Unfunded Mandates Reform Act of 
1995 is not required.

XIII. Request for Comments

    Interested persons may, on or before (insert date 90 days after 
date of publication in the Federal Register), submit to the Dockets 
Management Branch (address above) written comments regarding this 
document. 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.

    Dated: May 17, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-13470 Filed 5-27-99; 8:45 am]
BILLING CODE 4160-01-F