Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant

[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Rules and Regulations]
[Pages 20350-20352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-07367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2026-N-2887]


Medical Devices; Orthopedic Devices; Classification of the Manual 
Surgical Instrument for Appropriate Patient Selection for Orthopedic 
Implant

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 the manual surgical instrument for appropriate patient 
selection for orthopedic implant 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 classification 
of the manual surgical instrument for appropriate patient selection for 
orthopedic implant. 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 April 16, 2026. The classification was 
applicable on May 28, 2019.

FOR FURTHER INFORMATION CONTACT: David Hwang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4568, Silver Spring, MD 20993-0002, 301-796-3217, 
David.Hwang@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the manual surgical instrument for 
appropriate patient selection for orthopedic implant 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 of announcing the classification.
    Alternatively, under section 513(f)(6)(C) of the FD&C Act, a person 
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

[[Page 20351]]

the PMA or 510(k). Upon granting, FDA will publish a notice in the 
Federal Register within 30 days of announcing the classification.

II. Accessory Classification

    On March 4, 2019, FDA received Intrinsic Therapeutics Inc.'s 
request for accessory classification of the Defect Measurement Tool for 
the Barricaid Anular Closure Device. 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 May 28, 2019, 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 
888.4510.\1\ We have named the generic type of device ``manual surgical 
instrument for appropriate patient selection for orthopedic implant,'' 
and it is identified as an orthopedic manual surgical instrument used 
to measure an anatomical feature(s) to determine appropriate patient 
selection for an orthopedic implant. The characteristics of the 
instrument are defined by the specifications set for the orthopedic 
implant in terms of geometry, surgical technique and use of the device.
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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--Manual Surgical Instrument for Appropriate Patient Selection
          for Orthopedic Implant 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, and
                                          Labeling.
Improper assessment of size of defect..  Nonclinical performance
                                          testing.
Inadvertently enlarging the size of the  Nonclinical performance
 defect.                                  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.
    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 type. 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 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 
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 21 CFR part 820 regarding quality management 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 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.  888.4510 to subpart E to read as follows:


Sec.  888.4510  Manual surgical instrument for appropriate patient 
selection for orthopedic implant.

    (a) Identification. This device is an orthopedic manual surgical 
instrument used to measure an anatomical

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feature(s) to determine appropriate patient selection for an orthopedic 
implant. The characteristics of the instrument are defined by the 
specifications set for the orthopedic implant in terms of geometry, 
surgical technique and use of the device.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Technical specifications regarding geometry of the instruments 
must be identified and validated to demonstrate that the instruments 
accurately measure the critical geometry for patient selection of the 
intended orthopedic implant.
    (2) The use of the instruments is validated to demonstrate that the 
measurement process does not alter the patient anatomy which is being 
measured.
    (3) The patient contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Labeling must include:
    (i) Identification of orthopedic 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. 2026-07367 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P