Rule2025-16039
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 21, 2025
Effective
August 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with total disc replacement devices 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 classification of orthopedic manual surgical instrumentation for use with total disc replacement devices. We are taking this action because we have determined that classifying the device into class II 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, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Pages 40732-40734]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16039]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2025-N-2520]
Medical Devices; Orthopedic Devices; Classification of Orthopedic
Manual Surgical Instrumentation for Use With Total Disc Replacement
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying orthopedic manual surgical instrumentation for use with
total disc replacement devices 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 classification of
orthopedic manual surgical instrumentation for use with total disc
replacement devices. We are taking this action because we have
determined that classifying the device into class II 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, in part by reducing regulatory burdens.
DATES: This order is effective August 21, 2025. The classification was
applicable on June 24, 2020.
FOR FURTHER INFORMATION CONTACT: Michael Molyneaux-Francis, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4508, Silver Spring, MD 20993-0002,
240-402-5178, <a href="/cdn-cgi/l/email-protection#d39ebab0bbb2b6bffd9ebcbfaabdb6b2a6abfeb5a1b2bdb0baa093b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="f5b89c969d949099dbb89a998c9b9094808dd89387949b969c86b5939194db9d9d86db929a83">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified orthopedic manual surgical
instrumentation for use with total disc replacement devices as class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness for its intended use. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into the appropriate device class based on risk and
the regulatory controls sufficient to provide reasonable assurance of
safety and effectiveness.
FDA may classify a device through an accessory classification
request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of
the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision
allows manufacturers or importers to request classification of an
accessory distinct from another device upon written request. The
classification is based on the risks of the accessory when used as
intended as well as the level of regulatory controls necessary to
provide a reasonable assurance of safety and effectiveness,
notwithstanding the classification of any other device with which such
accessory is intended to be used. Until an accessory is reclassified by
FDA, the classification of any accessory distinct from another device
by regulation or written order issued prior to December 13, 2016, will
continue to apply.
Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or
importer may request appropriate classification of an accessory that
has been granted marketing authorization as part of a premarket
approval application (PMA), premarket notification (510(k)), or De Novo
classification request. FDA must grant or deny the request not later
than 85 days after receipt and, if granting, publish a notice in the
Federal Register within 30 days announcing the classification.
Alternatively, under section 513(f)(6)(C) of the FD&C Act, a person
[[Page 40733]]
filing a PMA or 510(k) may include a written request for the proper
classification of an accessory that has not been classified distinctly
from another device based on the risks of the accessory when used as
intended and the level of regulatory controls necessary to provide a
reasonable assurance of safety and effectiveness. When the written
request is included in a submission for marketing authorization, FDA
must grant or deny the request along with the response to the PMA or
510(k). Upon granting, FDA will publish a notice in the Federal
Register within 30 days announcing the classification.
II. Accessory Classification
On March 31, 2020, FDA received Spinal Kinetics LLC's request for
accessory classification of M6-C Artificial Cervical Disc
Instrumentation. 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 section 513(a)(1)(B) of the FD&C Act). 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 June 24, 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
888.4515.\1\ We have named the generic type of device ``orthopedic
manual surgical instrumentation for use with total disc replacement
devices,'' and they are identified as non-powered hand-held devices
designed specifically for use with a total disc replacement device and
interface with the associated implant for the purpose of insertion,
removal, placement, or repositioning, or to cut, rasp, or create a
defect specific to the features of the associated implant. This type of
device includes instruments specific to the geometry of the implant.
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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--Orthopedic Manual Surgical Instrumentation for Use With Total
Disc Replacement Devices Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction........... Biocompatibility evaluation.
Infection......................... Reprocessing validation,
Sterilization validation, and
Labeling.
Implant damage or malpositioning.. Validation of technical
specifications, and
Labeling.
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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 final order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) if, after notice of our intent to exempt and consideration of
comments, we determine that premarket notification is not necessary to
provide reasonable assurance of safety and effectiveness of the device.
At a future date, we may publish a separate notice in the Federal
Register announcing our intent to exempt this device.
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 part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in the guidance document ``Medical Device Accessories-
Describing Accessories and Classification Pathways'' have been approved
under OMB control number 0910-0823; the collections of information in
part 814, subparts A through E, regarding premarket approval have been
approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 820 regarding quality system regulation have
been approved under OMB control number 0910-0073; the collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120; and
the collections of information in part 801 regarding labeling have been
approved under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 888
Medical devices.
[[Page 40734]]
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. 888.4515 to subpart E to read as follows:
Sec. 888.4515 Orthopedic manual surgical instrumentation for use with
total disc replacement devices.
(a) Identification. Orthopedic manual surgical instrumentation for
use with total disc replacement devices are non-powered hand-held
devices designed specifically for use with a total disc replacement
device and interface with the associated implant for the purpose of
insertion, removal, placement, or repositioning, or to cut, rasp, or
create a defect specific to the features of the associated implant.
This type of device includes instruments specific to the geometry of
the implant.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Technical specifications regarding geometry of the instruments
must be specified and validated to demonstrate that the instruments can
safely position, place, or remove the implant.
(2) The patient contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable
devices that are provided non-sterile, or sterilization of devices
provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been
validated for use together; and
(ii) Validated methods and instructions for reprocessing any
reusable parts.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16039 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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