[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Pages 12088-12093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2015-N-3785]
RIN 0910-AI00


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final rule to classify posterior cervical screw systems into 
class II (special controls) and to continue to require a premarket 
notification (510(k)) to provide a reasonable assurance of safety and 
effectiveness of the device. A posterior cervical screw system is a 
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 thoracolumbosacral pedicle screw systems for use 
in other spinal regions.

DATES: This rule is effective May 1, 2019.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Genevieve McRae, 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: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Specific Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference

I. Executive Summary

A. Purpose of the Final Rule

    Through this final rule, FDA is classifying posterior cervical 
screw systems (product code NKG) into class II (special controls). This 
decision was based upon the recommendation of the Orthopaedic and 
Rehabilitation Devices Panel (the Panel) and our consideration and 
analysis of the public comments received following the publication of 
the proposed rule. FDA believes that the special controls established 
and imposed by this final rule, together with

[[Page 12089]]

the general controls, will provide a reasonable assurance of safety and 
effectiveness of the device.

B. Summary of the Major Provisions of the Final Rule

    This final rule revises the identification language for posterior 
cervical screw systems, classifies posterior cervical screw systems 
into class II (special controls), and establishes the following special 
controls for posterior cervical screw systems with which manufacturers 
must comply: (1) The design characteristics of the device ensure that 
the geometry and material composition are consistent with the intended 
use of the device; (2) nonclinical performance testing must demonstrate 
mechanical function and durability of the implant; (3) device 
components 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; and (5) device labeling must include a clear 
description of the technological features of the device, the intended 
use and indications for use, and certain specified device-specific 
warnings, precautions, and contraindications.

C. Legal Authority

    FDA is issuing this rule under the authority of the provisions of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to 
medical devices (21 U.S.C. 301 et seq.), including section 513(a) 
regarding device classes (21 U.S.C. 360c(a)), section 513(b) and (c) 
regarding device classification panels, and section 513(d) regarding 
device classification.

D. Costs and Benefits

    We estimate that the final rule will affect 32 manufacturers of 38 
products. Manufacturers of these affected products will incur one-time 
costs of $78.69 each to read and understand the rule, and will incur 
one-time labeling costs of $13,189 for each product. The present value 
of the total costs is estimated at $503,700. The annualized cost of 
this rule over 10 years is estimated to be $62,777 at a 7 percent 
discount rate and $52,853 at a 3 percent discount rate. We did not 
estimate quantifiable benefits of the final rule.

II. Background

A. History of This Rulemaking

    In the Federal Register of March 10, 2016 (81 FR 12607), FDA issued 
a proposed rule to classify posterior cervical screw systems as class 
II with special controls, and proposed special controls for these 
devices, and invited interested persons to comment on the proposed 
regulation by June 8, 2016. These recommendations were based upon 
feedback received from the Panel on September 21, 2012.

B. Summary of Comments to the Proposed Rule

    FDA received four sets of comments on the proposed rule from trade 
organizations, professional societies, and an individual. The comments 
within the scope of FDA's proposal to classify posterior cervical screw 
systems into class II (special controls) were supportive and included a 
few suggested clarifications and/or changes to the language of the 
proposed rule. We considered all comments in the development of this 
final rule and accepted several suggested changes, as discussed in 
section IV below.

III. Legal Authority

    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. The FD&C Act establishes three categories (classes) of 
devices, reflecting the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness (section 513(a) 
of the FD&C Act). The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Class I devices are those devices for which the general controls of 
the FD&C Act (controls authorized by or under the general controls 
sections of the FD&C Act (sections 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 a reasonable 
assurance of the safety and effectiveness of the device; or those 
devices for which insufficient information exists to determine that 
general controls are sufficient to provide reasonable assurance of the 
safety and effectiveness of the device 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 the 
safety and effectiveness, and for which there is sufficient information 
to establish special controls to provide such assurance, including the 
promulgation of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and other appropriate actions as 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.'' Pursuant to 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 (section 513(d)(1) of the FD&C 
Act). FDA has classified most preamendments devices under these 
procedures and has followed these procedures to classify posterior 
cervical screw systems.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    FDA received four sets of comments on the proposed rule by the 
close of the comment period. One of the comments received was regarding 
a different device type that is not associated with posterior cervical 
screw systems and is thus outside the scope of the rule. We describe 
and respond to the applicable comments in section IV.B and C. We have 
grouped certain comments under the same number because the subject 
matter of the comments is similar; conversely, in some cases, we have 
separated different issues discussed in the same comment and designated 
them as distinct comments, with separate numbers. The number assigned 
to each comment or comment topic is purely for organizational purposes 
and does not signify the comment's value or

[[Page 12090]]

importance or the order in which it was received.

B. Description of General Comments and FDA Response

    All comments within the scope of the rulemaking support FDA's 
proposed classification of posterior cervical screw systems into class 
II (special controls). One commenter notes that it supports the 
proposed classification of the device because ``the use of posterior 
cervical screw systems has been the standard of care for surgical 
management of cervical spine disorders arising from tumor, trauma, 
degerative [sic] disease and deformity for approximately 20 years.'' 
FDA agrees that the device type is well understood, which enables the 
establishment of special controls that provide a reasonable assurance 
of safety and effectiveness for these devices.

C. Specific Comments and FDA Response

    (Comment 1) A commenter suggests removing the phrase ``utilizing 
pedicle and lateral mass screws'' when identifying and referring to 
posterior cervical screw systems as there are additional screw types 
that fall within these systems.
    (Response 1) FDA agrees with this comment and has revised each 
relevant instance of this language within the regulation accordingly 
(i.e., the recommended Precaution statement in Sec.  
888.3075(b)(5)(iii)(A) (21 CFR 888.3075(b)(5)(iii)(A)).
    (Comment 2) A commenter recommends revising the proposed 
identification of ``posterior cervical screw systems'' to remove the 
specification of spinal levels for specific screw types listed in the 
identification and replacing it with a range of spinal levels 
applicable to all screw types utilized in the device.
    (Response 2) FDA disagrees with the proposed edits to the 
identification language. Evidence in the scientific literature is not 
adequate to support the use of pars screws, translaminar screws, and 
transarticular screws outside of the specified level (C2) based upon 
anatomic differences between C2 and other levels. Therefore, this 
change is not accepted.
    (Comment 3) A commenter notes that, while the preamble to the 
proposed rule specified that posterior cervical screw systems do not 
include dynamic features, the examples of dynamic features listed in 
the proposed identification language included ``non-uniform'' elements, 
which could be interpreted to include dual-diameter rods that may be a 
component of current posterior cervical screw systems. A dual-diameter 
rod is a rigid rod that transitions between two different diameters 
along its length.
    (Response 3) FDA agrees that dual-diameter rods are often part of 
rigid posterior cervical screw systems and that the proposed 
identification language should be revised to clarify that dual diameter 
rods or plate/rod combinations are examples of ``longitudinal 
members,'' which may be included in posterior cervical screw systems. 
We have also revised the identification to specify that posterior 
cervical screw systems are rigidly fixed devices that do not contain 
dynamic features, including but not limited to, non-uniform 
longitudinal elements or features that allow more motion or flexibility 
compared to rigid systems.
    (Comment 4) A commenter notes inconsistencies or errors in the 
indications for use in the proposed rule.
    (Response 4) FDA agrees with this comment and has revised the 
indications for use within Sec.  888.3075 to correct the noted errors. 
FDA has also clarified the language specifying the indications for use 
by replacing ``degenerative disease'' with ``degeneration'' to more 
appropriately reference the state to be treated and replacing 
``radiographic studies'' with ``imaging studies (radiographs, computed 
tomography, magnetic resonance imaging)'' to account for the various 
imaging modalities that may be used in preoperative planning prior to 
implantation of a posterior cervical screw system.
    (Comment 5) A commenter suggests that ``wear'' be removed from the 
list of potential means by which a device could fail.
    (Response 5) FDA disagrees with this comment. Posterior cervical 
screw systems are comprised of multiple interconnecting components that 
have the potential to generate wear during spinal motion. Therefore, 
the definition of device failure has not been modified.
    (Comment 6) A commenter recommends removing ``design 
characteristics'' as a special control because this item should be a 
requirement of all premarket notifications.
    (Response 6) FDA disagrees with this comment. FDA considers the 
``design characteristics'' special control necessary to help 
differentiate technological features for rigid posterior cervical screw 
systems, included within the scope of this regulation, from features 
considered to be dynamic.
    (Comment 7) A commenter recommends revising the biocompatibility 
special control to be ``compliance with biocompatibility standards'' 
rather than ``[d]evice components must be demonstrated to be 
biocompatible'' because the majority of posterior cervical screw 
systems are made of materials that have a long history of safe use and, 
as such, are compatible with standards. Testing for compliance with 
biocompatibility standards would be relevant only for alternative or 
new materials.
    (Response 7) FDA disagrees with this comment. The FD&C Act and 
FDA's regulations allow for flexibility in the methods for addressing 
certain regulatory requirements. Specifically, the substantial 
equivalence section of the FD&C Act (section 513(i)(1)(D)) states 
whenever the Secretary of Health and Human Services (the Secretary) 
requests information to demonstrate that devices with differing 
technological characteristics are substantially equivalent, the 
Secretary shall only request information that is necessary to making 
substantial equivalence determinations. In making such a request, the 
Secretary shall consider the least burdensome means of demonstrating 
substantial equivalence and request information accordingly. Hence, 
there may be alternatives to FDA-recognized consensus standards to 
satisfy the special control related to the biocompatibility of devices 
within this device type.
    (Comment 8) A commenter suggests modifying the first precaution 
within the labeling special control (Sec.  888.3075(b)(5)(iii)(a)) to 
include ``nerve roots'' as an anatomical structure to consider during 
preoperative planning.
    (Response 8) FDA agrees with this comment. This precaution has been 
revised to include a reference to ``neurologic structures.''
    (Comment 9) A commenter suggests that, within the Economic Analysis 
section of the proposed rule, it is unclear whether or not the required 
addition of precautions to the device labeling would require 
manufacturers to submit a new 510(k) for devices already on the market 
and recommends that we explicitly state that such a submission would 
not be required to revise the labeling for devices already on the 
market to add the precautions.
    (Response 9) FDA disagrees with this comment. As in the proposed 
rule, the language in the Economic Analysis of the final rule (see Ref. 
1) states, ``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 special 
controls,'' which includes the

[[Page 12091]]

addition of the specified precaution statement.
    (Comment 10) A commenter recommends minor editorial revisions to 
the risks and descriptive text associated with risks as outlined in the 
proposed rule.
    (Response 10) FDA disagrees with this comment. The recommended 
edits were minor and would not substantively change the meaning of the 
risks and associated mitigations for the device; therefore, we do not 
accept these suggested edits in this final rule.

V. Effective Date

    This final rule will become effective 30 days after its publication 
in the Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, 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). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this final 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. We have identified 16 manufacturers that could be considered 
small entities. Two of these manufacturers each produce two devices 
covered by this rule. Because our final regulatory impact analysis 
finds that more small entities will incur relatively low costs to 
comply with the final rule than estimated in our preliminary regulatory 
impact analysis, we have decided not to certify the final rule and find 
that the final 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 issuing ``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 $150 
million, using the most current (2017) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    This final rule classifies posterior cervical screw systems as 
class II devices with special controls. Although these devices are 
currently unclassified, manufacturers are subject to premarket 
requirements similar to class II devices, with manufacturers receiving 
clearance to market via a 510(k) submission without a PMA requirement. 
We have concluded that special controls in addition to general controls 
are sufficient to reasonably ensure the safety and effectiveness of 
these devices and that these devices may be classified as class II 
(special controls).
    Table 1 provides the Regulatory Information Service Center and 
Office of Information and Regulatory Affairs Combined Information 
System accounting information for this analysis.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Units
                                     Primary                                    ------------------------------------------------
            Category                estimate      Low estimate    High estimate                   Discount rate  Period covered           Notes
                                                                                  Year dollars         (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized         ..............  ..............  ..............            2016               7              10  .......................
     $millions/year.                                                                       2016               3              10
    Annualized Quantified......  ..............  ..............  ..............            2016               7              10  .......................
                                                                                           2016               3              10
    Qualitative
Costs:
    Annualized Monetized                  0.063  ..............  ..............            2016               7              10  .......................
     $millions/year.                      0.053                                            2016               3              10
    Annualized Quantified......  ..............  ..............  ..............            2016               7              10  .......................
                                                                                           2016               3              10
    Qualitative
Transfers:
    Federal Annualized           ..............  ..............  ..............            2016               7              10  .......................
     Monetized $millions/year.                                                             2016               3              10
                                ------------------------------------------------------------------------------------------------------------------------
                                 From:
                                 To:                                             ..............
                                ------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized   ..............  ..............  ..............            2016               7              10  .......................
     $millions/year.                                                                       2016               3              10
                                ------------------------------------------------------------------------------------------------------------------------
                                 From:
                                 To:                                             ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2, we estimate present 
and annualized values of costs and cost savings over an infinite time 
horizon. Based on these costs, we consider this final rule a regulatory 
action under Executive Order 13771.

[[Page 12092]]



                                                            Table 2--E.O. 13771 Summary Table
                                               [In $ millions 2016 dollars, over an infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................             0.5  ..............  ..............             0.5  ..............  ..............
Present Value of Cost Savings...........................  ..............  ..............  ..............  ..............  ..............  ..............
Present Value of Net Costs..............................             0.5  ..............  ..............             0.5  ..............  ..............
Annualized Costs........................................           0.033  ..............  ..............           0.015  ..............  ..............
Annualized Cost Savings.................................  ..............  ..............  ..............  ..............  ..............  ..............
Annualized Net Costs....................................           0.033  ..............  ..............           0.015  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 1) and at 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Analysis of Environmental Impact

    We have 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.

VIII. Paperwork Reduction Act of 1995

    This final 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 (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; and the 
collections of information in 21 CFR part 807 have been approved under 
OMB control number 0910-0625. The precaution labeling provisions in 
Sec.  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 in Sec.  888.3075(b)(5)(iii)(A) and 
(b)(5)(iii)(B) is 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)).

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

X. Reference

    The following reference is on display at the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

    1. The full analysis of economic impacts is available in Docket 
No. FDA-2015-N-3785 for this final rule at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.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, 21 CFR part 
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 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 are comprised 
of multiple, interconnecting components, made from a variety of 
materials that allow an implant system to be built from the occiput to 
the upper thoracic spine to fit the patient's anatomical and 
physiological requirements, as determined by preoperative cross-
sectional imaging. Such a spinal assembly consists of a combination of 
bone anchors 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, including dual diameter rods, plate/rod combinations), transverse 
or cross connectors, interconnection mechanisms (e.g., rod-to-rod 
connectors, offset connectors), and closure mechanisms (e.g., set 
screws, nuts). Posterior cervical screw systems are rigidly fixed 
devices that do not contain dynamic features, including but not limited 
to: non-uniform longitudinal elements or features that allow more 
motion or flexibility compared to rigid systems.
    Posterior cervical screw systems are intended to provide 
immobilization and stabilization of spinal segments in patients as an 
adjunct to fusion for acute and chronic instabilities of the cervical 
spine and/or craniocervical junction and/or cervicothoracic junction 
such as: (1) Traumatic spinal fractures and/or traumatic dislocations; 
(2) deformities; (3) instabilities; (4) failed previous fusions (e.g., 
pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal 
degeneration, including neck and/or arm pain of discogenic origin as 
confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration 
of the facets with instability; and (9) reconstruction following 
decompression to treat 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.

[[Page 12093]]

    (b) Classification. Class II (special controls). The special 
controls for posterior cervical screw systems are:
    (1) The 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 components 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 include the following:
    (i) A clear description of the technological features of the device 
including identification of device 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: Preoperative planning prior to implantation of 
posterior cervical screw systems should include review of cross-
sectional imaging studies (e.g., CT and/or MRI) to evaluate the 
patient's cervical anatomy including the transverse foramen, neurologic 
structures, and the course of the vertebral arteries. If any findings 
would compromise the placement of these 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) Cleaning and sterilization 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.

    Dated: March 22, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-06024 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P