[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Proposed Rules]
[Pages 12607-12613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2015-N-3785]


Medical Devices; Orthopedic Devices; Classification of Posterior 
Cervical Screw Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing 
to classify posterior cervical screw systems into class II (special 
controls) and to continue to require premarket notification to provide 
a reasonable assurance of safety and effectiveness of the device. A 
posterior cervical screw system is a prescription device used to 
provide immobilization and stabilization in the cervical spine as an 
adjunct to spinal fusion surgery. The term ``posterior cervical screw 
systems'' is used to distinguish these devices from currently 
classified pedicle screw spinal systems cleared for use in other spinal 
regions.

DATES: Submit either electronic or written comments by June 8, 2016. 
See section IV of this document for the proposed effective date of a 
final rule that may issue based on this proposal.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-3785 for ``Medical Devices; Orthopedic Devices; 
Classification of Posterior Cervical Screw Systems.''

[[Page 12608]]

Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Genevieve Hill, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1457, Silver Spring, MD 20993-0002, 301-796-6423, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory and Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
301 et seq.), as amended, established a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of 
devices, reflecting 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).
    Section 513(a) of the FD&C Act defines the three classes of 
devices. Class I devices are those devices for which the general 
controls of the FD&C Act (controls authorized by or under section 501, 
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 
360i, or 360j) or any combination of such sections) are sufficient to 
provide reasonable assurance of safety and effectiveness; or those 
devices for which insufficient information exists to determine that 
general controls are sufficient to provide reasonable assurance of 
safety and effectiveness or to establish special controls to provide 
such assurance, but because the devices are not purported or 
represented to be for a use in supporting or sustaining human life or 
for a use which is of substantial importance in preventing impairment 
of human health, and do not present a potential unreasonable risk of 
illness or injury, are to be regulated by general controls (section 
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for 
which general controls by themselves are insufficient to provide 
reasonable assurance of safety and effectiveness, but for which there 
is sufficient information to establish special controls to provide such 
assurance, including the issue of performance standards, postmarket 
surveillance, patient registries, development and dissemination of 
guidelines, recommendations, and other appropriate actions the Agency 
deems necessary to provide such assurance (section 513(a)(1)(B) of the 
FD&C Act). Class III devices are those devices for which insufficient 
information exists to determine that general controls and special 
controls would provide a reasonable assurance of safety and 
effectiveness, and are purported or represented for a use in supporting 
or sustaining human life or for a use which is of substantial 
importance in preventing impairment of human health, or present a 
potential unreasonable risk of illness or injury (section 513(a)(1)(C) 
of the FD&C Act).
    FDA refers to devices that were in commercial distribution before 
May 28, 1976 (the date of enactment of the Medical Device Amendments of 
1976), as ``preamendments devices.'' Under section 513(d)(1) of the 
FD&C Act, FDA classifies these devices after FDA: (1) Receives a 
recommendation from a device classification panel (an FDA advisory 
committee); (2) publishes the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and (3) publishes a 
final regulation classifying the device. FDA has classified most 
preamendments devices under these procedures.
    A person may market a preamendments device that has been classified 
into class III and devices found to be substantially equivalent by 
means of premarket notification procedures (510(k)) to such a 
preamendments device or to a device within that type without submission 
of a premarket approval application (PMA) until FDA issues a final 
order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) 
requiring premarket approval or until the device is subsequently 
reclassified into class I or class II.
    FDA refers to devices that were not in commercial distribution 
prior to May 28, 1976 as ``postamendments devices.'' These devices are 
automatically classified by statute (section 513(f) of the FD&C Act) 
into class III without any FDA rulemaking process. These 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 FD&C Act, to a predicate device that does not require premarket 
approval. The Agency determines whether new devices are substantially 
equivalent to predicate devices by means of premarket notification 
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 
part 807 of the regulations (21 CFR part 807).

B. Regulatory History of the Device

    The regulatory history of posterior cervical screw systems arose 
from that of pedicle screw spinal systems, which are medical devices 
similar in design and principle of operation, but differ based on 
anatomic use in the spine and their indications for use. Both device 
systems are comprised of various interconnecting components such as 
longitudinal members (i.e., rods, plates) and screws that are 
configured per the

[[Page 12609]]

patient's anatomy and implanted into the posterior spine to provide 
stabilization as bony fusion occurs. After the enactment of the Medical 
Device Amendments of 1976, FDA commenced to identify and classify all 
preamendments devices, in accordance with section 513(b) of the FD&C 
Act. In the Federal Register of September 4, 1987 (52 FR 33686), FDA 
classified a total of 77 generic types of orthopedic devices. Neither 
pedicle screw spinal systems nor posterior cervical screw systems were 
identified in this initial effort.
    In July 1998, FDA issued a final rule (63 FR 40025, July 27, 1998) 
classifying pedicle screw spinal systems as class II devices, and a 
technical amendment to this rule was published on May 22, 2001 (66 FR 
28051). In the technical amendment, FDA noted that pedicle screw 
systems for the following intended uses in the cervical spine (which 
are now referred to as posterior cervical screw systems) were in use 
prior to May 28,1976 and are therefore considered preamendments 
devices: (1) Cervical spondylolisthesis (all grades and types); (2) 
cervical spondylolysis; (3) cervical degenerative disc disease; (4) 
degeneration of the cervical facets accompanied by instability; (5) 
cervical trauma (fracture and dislocation); and (6) revision of failed 
previous fusion surgery (pseudarthrosis) of the cervical spine. Since 
2001, FDA has regulated posterior cervical screw systems as 
unclassified preamendments devices requiring premarket notification 
(510(k)). Posterior cervical screw systems currently on the market have 
been determined to be substantially equivalent to devices that were in 
commercial distribution prior to May 28, 1976.
    On April 9, 2009, FDA published an order under sections 515(i) and 
519 of the FD&C Act (515(i) order) for the submission of safety and 
effective information on pedicle screw spinal systems with certain 
indications for use (74 FR 16214). In response to that order, FDA 
received a request from the Orthopedic Surgical Manufacturers 
Association (OSMA) to classify posterior cervical screw systems into 
class II (special controls). Because this request was considered to be 
outside the scope of the 515(i) order related to pedicle screw spinal 
systems, FDA requested that OSMA submit a separate petition for 
classification of posterior cervical screw systems. OSMA submitted the 
requested petition on November 22, 2011, under Docket No. FDA-2011-P-
0851-0001/CCP (Ref. 1). FDA consulted with the Orthopaedic and 
Rehabilitation Devices Panel (the Panel), an FDA advisory committee, 
regarding the classification of this device type on September 21, 2012 
(Ref. 2). At the Panel meeting, the Panel recommended that posterior 
cervical screw systems be classified as class II with special controls.

II. Recommendation of the Panel

    During a public meeting held on September 21, 2012, the Panel made 
recommendations regarding the classification and regulatory controls 
for posterior cervical screw systems.

A. Identification

    FDA is proposing the following identification for posterior 
cervical screw systems based on the Panel's recommendations and the 
Agency's review. Posterior cervical screw systems utilizing pedicle and 
lateral mass screws, implanted from the C1 to C7 levels, are multiple 
component devices, made from a variety of materials, including metallic 
alloys. Posterior cervical instrumentation generally involves use of a 
fixation system comprised of both longitudinal members and screws that 
can span various combinations of spinal levels from the occiput to the 
upper thoracic spine. Cervical lateral mass and pedicle screws serve as 
the primary bone anchor points and require selection based on 
individual patient anatomy, as determined by preoperative cross-
sectional imaging. Posterior cervical screw systems consist of a bone 
anchor via screws (i.e., occipital screws, cervical lateral mass 
screws, cervical pedicle screws, C2 pars screws, C2 translaminar 
screws, C2 transarticular screws), longitudinal members (e.g., plates, 
rods) and optional transverse connectors. An interconnection mechanism 
(e.g., offset connector, nuts, screws, or bolts) may be utilized to 
link the anchor and longitudinal member. These posterior cervical screw 
systems are statically fixed devices, only intended to be used as an 
adjunct to fusion and do not include any dynamic features, which may 
include, but are not limited to: Non-uniform and/or non-metallic 
longitudinal elements, features that allow more motion or flexibility 
compared to traditional rigid systems, or features that do not provide 
the system immediate rigid fixation.

B. Recommended Classification of the Panel

    The Panel recommended that posterior cervical screw systems be 
classified into class II (special controls).

C. Summary of Reasons for Recommendation

    The Panel considered the panel members' personal knowledge of and 
clinical experience with the device type, as well as the history of 
safety and effectiveness of the device over many years of clinical use. 
The Panel recommended that posterior cervical screw systems be 
classified into class II as an adjunct to fusion for the following 
acute and chronic instabilities of the cervical spine and 
craniocervical junction: (1) Traumatic spinal fractures and/or 
traumatic dislocations; instability or deformity; (2) failed previous 
fusions (e.g., pseudarthrosis); (3) tumors involving the cervical 
spine; and (4) degenerative disease, including intractable 
radiculopathy and/or myelopathy, neck and/or arm pain of discogenic 
origin as confirmed by radiographic studies, and degenerative disease 
of the facets with instability. These systems are also intended to 
restore the integrity of the spinal column even in the absence of 
fusion for a limited time period in patients with advanced stage tumors 
involving the cervical spine in whom life expectancy is of insufficient 
duration to permit achievement of fusion. The Panel also found that 
there is reasonable evidence to support use of posterior cervical 
screws as an adjunct to fusion in the pediatric population. In 
addition, there was panel consensus supporting the use of posterior 
cervical screws for non-fusion treatment for a limited time period in 
patients with advanced stage tumors involving the cervical spine in 
whom life expectancy is of insufficient duration to permit achievement 
of fusion; the Panel emphasized that their discussions were limited to 
this narrow patient population and should not be extrapolated to other 
non-fusion applications or technologies (e.g., dynamic stabilization 
systems).
    The Panel also recommended that posterior cervical screw systems be 
classified into class II because special controls, together with 
general controls, would provide reasonable assurance of their safety 
and effectiveness. The risks to health for this device type are known 
and can be adequately mitigated by special controls (such as mechanical 
testing, biocompatibility, and labeling).

D. Risks to Health

    Based on the Panel's discussion and recommendations in addition to 
comprehensive literature reviews and analyses by OSMA and FDA, the 
risks to health associated with posterior cervical screw systems and 
the proposed measures to mitigate these

[[Page 12610]]

risks are identified in the following list and in table 1. The 
identified risks to health are identical to those proposed by FDA 
during the September 21, 2012, panel meeting, with the addition of 
risks associated with the presence of vertebral arteries, as 
recommended by FDA with panel agreement. FDA determined that the 
following risks to health are associated with its use:
     Device failure--Components may deform, fracture, wear, 
loosen, or disassemble, resulting in a mechanical or functional 
failure.
     Failure at the bone/implant interface--Components may 
loosen or disengage from the bone.
     Tissue injury--Intraoperative and postoperative risks of 
tissue injury include: Bone fracture, injury to blood vessels or 
viscera, neurologic injury, dural tear or cerebrospinal fluid leak, 
skin penetration or irritation, and postoperative wound problems, 
including infection, hematoma/seroma.
     Adverse tissue reactions--Adverse tissue reactions 
include: Foreign body response, metal allergy, and metal toxicity.
     Device malposition--Risks of device malposition may 
include difficulty or inability to implant the device components or 
incorrect placement of the device.
     Pseudarthrosis--The risk of nonunion, or pseudarthrosis, 
signifies failure of bony fusion and potential instability or pain.
     Adverse clinical sequelae--Adverse clinical sequelae may 
include the risk of new or unresolved neck pain, new or worsened 
neurologic deficit/injury, or loss of correction.
    The risks to health presented to the 2012 Panel such as cardiac, 
respiratory, and death are considered general surgical risks associated 
with the surgical procedure to implant posterior cervical screw 
systems; these risks are not directly associated with posterior 
cervical screw systems and therefore are not included in the previous 
list of risks. Failure of the posterior cervical screw system as a 
result of the risks to health listed may result in the need for 
reoperation, revision, or removal.
    While presented to the Panel as a potential risk, graft settling 
would not be considered a device-specific risk. Rather, it represents a 
potential mechanism for the development of pseudarthrosis, instability, 
or lack of correction. Further, graft settling is expected in patients 
undergoing fusion surgery and does not necessarily result in adverse 
clinical sequelae. Thus this item does not specifically appear in the 
previous list.

E. Proposed Special Controls

    FDA believes that the following special controls, in addition to 
general controls, are sufficient to mitigate the risks to health 
described in section II.D. and provide reasonable assurance of safety 
and effectiveness of the device.
     Design characteristics of the device, including 
engineering schematics, must ensure that the geometry and material 
composition are consistent with the intended use.
     Nonclinical performance testing must demonstrate the 
mechanical function and durability of the implant.
     Device must be demonstrated to be biocompatible.
     Validation testing must demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize, the device 
components and device-specific instruments.
     Labeling must bear all information required for the safe 
and effective use of the device, specifically including the following:
    [cir] Clear description of the technological features of the 
device, including identification of device materials and the principles 
of device operation;
    [cir] intended use and indications for use including levels of 
fixation;
    [cir] device-specific warnings, precautions, and contraindications 
that include the following statements:
    [ssquf] ``Precaution: Pre-operative planning prior to implantation 
of posterior cervical lateral mass and pedicle screw spinal systems 
should include review of cross-sectional imaging studies (e.g., CT and/
or MRI imaging) to evaluate the patient's cervical anatomy including 
the transverse foramen and the course of the vertebral arteries. If any 
findings would compromise the placement of lateral mass or pedicle 
screws, other surgical methods should be considered. In addition, use 
of intraoperative imaging should be considered to guide and/or verify 
device placement, as necessary.''
    [ssquf] ``Precaution: Use of posterior cervical pedicle screw 
fixation at the C3 through C6 spinal levels requires careful 
consideration and planning beyond that required for lateral mass screws 
placed at these spinal levels, given the proximity of the vertebral 
arteries and neurologic structures in relation to the cervical pedicles 
at these levels.''
    [cir] identification of magnetic resonance (MR) compatibility 
status;
    [cir] cleaning and sterilization instructions for devices and 
instruments that are provided non-sterile to the end user; and
    [cir] detailed instructions of each surgical step, including device 
removal, accompanied by magnified illustrations.
    Table 1 summarizes the risks to health described in section II.D. 
and the proposed special controls that are sufficient to mitigate these 
risks.

    Table 1--Summary of Risks to Health and Proposed Special Controls
------------------------------------------------------------------------
                                           Method of mitigation (i.e.,
             Risk to health                      special control)
------------------------------------------------------------------------
Device Failure.........................  Design Characteristics.
                                         Nonclinical Performance
                                          Testing.
                                         Labeling.
Failure of Bone Implant Interface......  Design Characteristics.
                                         Biocompatibility.
                                         Nonclinical Performance
                                          Testing.
                                         Labeling.
Tissue Injury..........................  Labeling.
Adverse Tissue Reactions...............  Design Characteristics.
                                         Biocompatibility.
                                         Sterility.
                                         Labeling.
Device Malposition.....................  Labeling.
Pseudarthrosis.........................  Nonclinical Performance
                                          Testing.
                                         Biocompatibility.
                                         Labeling.
Adverse Clinical Sequelae..............  Labeling.
------------------------------------------------------------------------


[[Page 12611]]

    Furthermore, FDA is proposing that posterior cervical screw systems 
be prescription devices. Prescription devices must be used in 
accordance with 21 CFR 801.109. Prescription-use restrictions are a 
type of general controls as defined in section 513(a)(1)(A)(i) of the 
FD&C Act.

III. Proposed Classification and FDA's Finding

    In preparation for the September 2012 panel meeting and to better 
inform the Agency's proposed classification of posterior cervical screw 
systems as described in this proposed rule, FDA conducted a review of 
the literature that included relevant scientific and medical 
information published through July 2012 (see Section 6 of FDA's Panel 
Executive Summary, Ref. 2) as well as adverse events in FDA's 
Manufacturer and User Facility Device Experience (MAUDE) database (see 
Section 7 of FDA's Panel Executive Summary, Ref. 2). FDA does not 
believe that new or different information has become available since 
the September 2012 panel meeting that would alter FDA's findings. Based 
upon FDA's review of the literature and adverse events and FDA's 
continued premarket and postmarket experience with the device type, FDA 
agrees with the Panel's recommendation that posterior cervical screw 
systems be classified into class II. FDA is proposing to classify these 
devices into class II because general controls alone are insufficient 
to provide reasonable assurance of the safety and effectiveness of 
these implantable devices (see section II.D.), as presented and 
discussed during the September 21, 2012, panel meeting (Ref. 2). FDA 
also believes there is sufficient information to establish special 
controls to mitigate the known risks of the device. Therefore, FDA 
proposes that posterior cervical screw systems be classified into class 
II. The special controls, in addition to general controls, will provide 
reasonable assurance of the safety and effectiveness of the device.

IV. Proposed Effective Date

    FDA proposes that this proposed rule, if finalized, will become 
effective 30 days after its date of publication in the Federal 
Register. In addition, FDA proposes that once the final rule is in 
effect, manufacturers of posterior cervical screw systems as defined in 
section II.A. that have not been offered for sale prior to the 
effective date of the final rule must obtain 510(k) clearance before 
marketing their devices and comply with the special controls.
    FDA notes that a firm who markets a device that is intended for use 
as a posterior cervical screw system as identified in section II.A., as 
well as other uses, that was legally in commercial distribution before 
May 28, 1976, or who markets a device found to be substantially 
equivalent to such a device and who does not intend to market such 
device for uses other than as a posterior cervical screw as defined in 
section II.A., may remove the other intended uses from the device's 
labeling and continue marketing the device without submitting a new 
510(k). In addition, such posterior cervical screw systems must comply 
with the special controls.

V. Environmental Impact, No Significant Impact

    The Agency has determined under 21 CFR 25.34(b) 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. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us 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). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. We believe that this 
proposed rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because: (1) The proposed regulation would classify a 
previously unclassified preamendment device type; (2) only five 
registered establishments are listed in the Establishment Registration 
and Device Listing database that would be affected by the proposed 
rule; and (3) the proposed regulation designating the classification of 
posterior cervical screw systems as class II is consistent with the 
historical regulatory oversight given to this device type, we proposed 
to certify that the rule will not have a significant economic impact on 
a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    This rule proposes to classify posterior cervical screw systems as 
class II devices with special controls. These devices are currently 
unclassified. Currently, manufacturers are subject to premarket 
requirements similar to class II devices, with producers receiving 
clearance to market via a 510(k) premarket notification submission 
without a PMA requirement. We have concluded that special controls in 
addition to general controls are sufficient for ensuring the safety and 
effectiveness of these devices and that these devices may be classified 
as class II (special controls).
    FDA's Registration and Listing database identifies two large 
manufacturers of three posterior cervical screw systems (product code 
NKG). Manufacturers of these devices will need to edit any current 
labeling to reflect requirements of the proposed rule. This is 
considered a major label change because of the addition of precaution 
statements. The estimated cost of this labeling change is $13,189 per 
product for an estimated total cost of $39,567 (3 x $13,189). Any 
currently marketed devices seeking marketing authorization as posterior 
cervical screw systems would incur similar costs. We welcome comments 
on the number of applications we may receive from firms pursuing 
marketing authorization for currently marketed products as posterior 
cervical screw systems.
    The proposed rule would require that manufacturers who wish to 
market these devices submit 510(k) premarket notifications and comply 
with the proposed special controls. It is not expected that 
manufacturers of devices already on the market would need to submit new 
510(k) notifications, 510(k) amendments, or add-to-files to demonstrate 
conformance with the proposed special controls. Any manufacturers 
seeking marketing authorization of posterior cervical screw systems 
would not incur additional

[[Page 12612]]

costs as a result of this rule because we already require 510(k) 
submissions for these devices. Hence, the proposed rule would not 
result in any significant change in how manufacturers prepare 510(k) 
submissions for the affected devices or in how we would review the 
submissions. Consequently, compliance with the special controls 
proposed for these devices would not yield significant new costs for 
manufacturers. Because the formal classification of the affected 
devices as class II is consistent with current Agency and industry 
practice, we conclude that the proposed rule, if finalized, would not 
impose any significant additional regulatory burden.
    We invite comments on this analysis.

VII. Paperwork Reduction Act of 1995

    This proposed rule establishes special controls that refer to 
currently approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of 
information in 21 CFR part 807, subpart E, have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
801 have been approved under OMB control number 0910-0485; the 
collections of information in 21 CFR part 807 have been approved under 
OMB control number 0910-0625. The precaution labeling provisions in 
proposed 21 CFR 888.3075(b)(5) are not subject to review by OMB because 
they do not constitute a ``collection of information'' under the PRA. 
Rather, the following labeling: (1) ``Precaution: Pre-operative 
planning prior to implantation of posterior cervical lateral mass and 
pedicle screw spinal systems should include review of cross-sectional 
imaging studies (e.g., CT and/or MRI imaging) to evaluate the patient's 
cervical anatomy including the transverse foramen and the course of the 
vertebral arteries. If any findings would compromise the placement of 
lateral mass or pedicle screws, other surgical methods should be 
considered. In addition, use of intraoperative imaging should be 
considered to guide and/or verify device placement, as necessary.'' (2) 
``Precaution: Use of posterior cervical pedicle screw fixation at the 
C3 through C6 spinal levels requires careful consideration and planning 
beyond that required for lateral mass screws placed at these spinal 
levels, given the proximity of the vertebral arteries and neurologic 
structures in relation to the cervical pedicles at these levels.'' are 
a ``public disclosure of information originally supplied by the Federal 
government to the recipient for the purpose of disclosure to the 
public'' (5 CFR 1320.3(c)(2)).

VIII. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

    1. Orthopedic Surgical Manufacturers Association Reclassification 
Petition filed on November 23, 2011, to support classification of 
pedicle and lateral mass screws for cervical spine use from 
unclassified status to class II. Available at www.regulations.gov, the 
docket number is FDA-2011-P-0851.
    2. Transcript and other meeting materials from the Food and Drug 
Administration Orthopedic Devices Panel Meeting, September 21, 2012, 
(http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm309184.htm).

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend 21 CFR part 888 as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for 21 CFR part 888 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.   888.3075 to subpart D to read as follows:


Sec.  888.3075  Posterior cervical screw system.

    (a) Identification. Posterior cervical screw systems, implanted 
from the C1 to C7 levels, are prescription devices comprised of 
multiple components, made from a variety of materials, including 
metallic alloys. Posterior cervical instrumentation generally involves 
use of a fixation system comprised of both longitudinal members and 
screws that can span various combinations of spinal levels from the 
occiput to the upper thoracic spine. Cervical lateral mass and pedicle 
screws serve as the primary bone anchor points and require selection 
based on individual patient anatomy, as determined by preoperative 
cross-sectional imaging. Posterior cervical screw systems consist of a 
bone anchor via screws (i.e., occipital screws, cervical lateral mass 
screws, cervical pedicle screws, C2 pars screws, C2 translaminar 
screws, C2 transarticular screws), longitudinal members (e.g., plates, 
rods) and optional transverse connectors. An interconnection mechanism 
(e.g., offset connector, nuts, screws, or bolts) may be utilized to 
link the anchor and longitudinal member. These posterior cervical screw 
systems are intended to provide immobilization and stabilization of 
spinal segments (C1 to C7 levels) in patients as an adjunct to fusion 
for the following acute and chronic instabilities of the cervical spine 
and/or craniocervical junction and/or cervicothoracic junction: 
Traumatic spinal fractures and/or traumatic dislocations; spinal 
deformities and related instabilities; failed previous fusions (e.g., 
pseudarthrosis); tumors involving the cervical spine; inflammatory 
disorders; degenerative disease, including neck and/or arm pain of 
discogenic origin as confirmed by radiographic studies; degenerative 
disease of the facets with instability; and reconstruction following 
decompression to treat intractable radiculopathy and/or myelopathy. 
These systems are also intended to restore the integrity of the spinal 
column even in the absence of fusion for a limited time period in 
patients with advanced stage tumors involving the cervical spine in 
whom life expectancy is of insufficient duration to permit achievement 
of fusion.
    (b) Classification. Class II (special controls). The special 
controls for posterior cervical screw systems are:
    (1) Design characteristics of the device, including engineering 
schematics, must ensure that the geometry and material composition are 
consistent with the intended use.
    (2) Nonclinical performance testing must demonstrate the mechanical 
function and durability of the implant.
    (3) Device must be demonstrated to be biocompatible.
    (4) Validation testing must demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize, the device 
components and device-specific instruments.
    (5) Labeling must bear all information required for the safe and 
effective use of the device, specifically including the following:
    (i) Clear description of the technological features of the device 
including identification of device

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materials and the principles of device operation;
    (ii) Intended use and indications for use including levels of 
fixation;
    (iii) Device specific warnings, precautions, and contraindications 
that include the following statements:
    (A) ``Precaution: Pre-operative planning prior to implantation of 
posterior cervical lateral mass and pedicle screw spinal systems should 
include review of cross-sectional imaging studies (e.g., CT and/or MRI 
imaging) to evaluate the patient's cervical anatomy including the 
transverse foramen and the course of the vertebral arteries. If any 
findings would compromise the placement of lateral mass or pedicle 
screws, other surgical methods should be considered. In addition, use 
of intraoperative imaging should be considered to guide and/or verify 
device placement, as necessary.''
    (B) ``Precaution: Use of posterior cervical pedicle screw fixation 
at the C3 through C6 spinal levels requires careful consideration and 
planning beyond that required for lateral mass screws placed at these 
spinal levels, given the proximity of the vertebral arteries and 
neurologic structures in relation to the cervical pedicles at these 
levels.''
    (iv) Identification of magnetic resonance (MR) compatibility 
status;
    (v) Sterilization and cleaning instructions for devices and 
instruments that are provided non-sterile to the end user, and;
    (vi) Detailed instructions of each surgical step, including device 
removal, accompanied by magnified illustrations.

    Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05384 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P