[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Rules and Regulations]
[Pages 11293-11295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2022-N-0114]


Medical Devices; Orthopedic Devices; Classification of the Screw 
Sleeve Bone Fixation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the screw sleeve bone fixation device into class II 
(special controls). The special controls that apply to the device type 
are identified in this order and will be part of the codified language 
for the screw sleeve bone fixation device's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices.

DATES: 
    This order is effective March 1, 2022. The classification was 
applicable on May 1, 2020.

FOR FURTHER INFORMATION CONTACT: Jesse Muir, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4508, Silver Spring, MD 20993-0002, 240-402-6679, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the screw sleeve bone fixation 
device as class II (special controls), which we have determined will 
provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, by placing the device into a lower device class 
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate device by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) established the first procedure for De 
Novo classification. Section 607 of the Food and Drug Administration 
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo 
application process by adding a second procedure. A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo 
process, the device can serve as a predicate for future devices of that 
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C 
Act). As a result, other device sponsors do not have to submit a De 
Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On December 13, 2018, FDA received Woven Orthopedic Technologies, 
LLC's request for De Novo classification of the OGmend[supreg] Implant 
System. FDA reviewed the request in order to classify the device under 
the criteria for classification set forth in section 513(a)(1) of the 
FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on May 1, 2020, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
888.3043.\1\ We have named the generic type of device ``screw sleeve 
bone fixation device,'' and it is intended to be implanted in 
conjunction with a non-resorbable, metallic bone screw where the screw 
has lost purchase due to loosening, backout, or breakage. The device 
fits between the screw threads and surrounding bone and provides 
increased surface area to create an

[[Page 11294]]

interference fit to restore stability of the implant construct.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

Table 1--Screw Sleeve Bone Fixation Device Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Loss of function/mechanical integrity    In vivo performance testing;
 resulting from:                          Non-clinical performance
[ssquf] Device malposition.               testing; Shelf life testing;
[ssquf] Device breakage.                  and Labeling.
[ssquf] Damage to screw during
 insertion.
[ssquf] Deterioration due to aging.
[ssquf] Insufficient restoration of
 screw fixation.
Revision...............................  In vivo performance testing;
                                          Non-clinical performance
                                          testing; and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation; In
                                          vivo performance testing; Non-
                                          clinical performance testing;
                                          and Labeling.
Infection..............................  Sterilization validation; and
                                          Shelf life testing.
Febrile response due to endotoxins.....  Pyrogenicity testing.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. We encourage sponsors to consult with us if they wish to 
use a non-animal testing method that they believe is suitable, 
adequate, validated, and feasible. We will consider if such an 
alternative method could be assessed for equivalency to an animal test 
method. This device is subject to premarket notification requirements 
under section 510(k) of the FD&C Act.

III. Analysis of Environmental 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. These collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections 
of information in 21 CFR part 860, subpart D, regarding De Novo 
classification have been approved under OMB control number 0910-0844; 
the collections of information in 21 CFR part 814, subparts A through 
E, regarding premarket approval, have been approved under OMB control 
number 0910-0231; the collections of information in part 807, subpart 
E, regarding premarket notification submissions, have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR part 820, regarding quality system regulation, have been 
approved under OMB control number 0910-0073; and the collections of 
information in 21 CFR part 801, regarding labeling, have been approved 
under OMB control number 0910-0485.

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.  888.3043 to subpart D to read as follows:


Sec.  888.3043  Screw sleeve bone fixation device.

    (a) Identification. A screw sleeve bone fixation device is intended 
to be implanted in conjunction with a non-resorbable, metallic bone 
screw where the screw has lost purchase due to loosening, backout, or 
breakage. The device fits between the screw threads and surrounding 
bone and provides increased surface area to create an interference fit 
to restore stability of the implant construct.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo performance testing under anticipated conditions of use 
must demonstrate:
    (i) The device provides sufficient stability to allow for fracture 
healing; and
    (ii) A lack of adverse biologic response to the implant through 
histopathological and histomorphometric assessment.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. 
Testing must:
    (i) Assess the stability of the device in a rescue screw scenario;
    (ii) Demonstrate that the device can be inserted and removed 
without damage to the implant or associated hardware;
    (iii) Demonstrate the device can withstand dynamic loading without 
device failure; and
    (iv) Characterize wear particle generation.
    (3) The device must be demonstrated to be biocompatible.
    (4) The device must be demonstrated to be non-pyrogenic.
    (5) Performance data must demonstrate the sterility of the device.
    (6) Performance data must support the labeled shelf life of the 
device by demonstrating continued sterility, package integrity, and 
device functionality over the established shelf life.
    (7) Labeling must include:
    (i) A detailed summary of the device technical parameters;
    (ii) Information describing all materials of the device;
    (iii) Instructions for use, including device removal; and
    (iv) A shelf life.


[[Page 11295]]


    Dated: February 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04154 Filed 2-28-22; 8:45 am]
BILLING CODE 4164-01-P


