# Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant
> **Food and Drug Administration** · Final amendment; final order. · Published 2026-04-16 · Effective 2026-04-16 · 91 FR 20350
## Document
- **Document number:** 2026-07367
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 91 FR 20350
- **CFR reference:** 21 CFR 888
- **Publication date:** 2026-04-16
- **Effective date:** 2026-04-16
- **HHS docket:** Docket No. FDA-2026-N-2887
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2026/04/16/2026-07367/medical-devices-orthopedic-devices-classification-of-the-manual-surgical-instrument-for-appropriate)
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