Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3790](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3790) → KYN — Prosthesis, Wrist, Constrained, Metal

# KYN · Prosthesis, Wrist, Constrained, Metal

_Orthopedic · 21 CFR 888.3790 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYN

## Overview

- **Product Code:** KYN
- **Device Name:** Prosthesis, Wrist, Constrained, Metal
- **Regulation:** [21 CFR 888.3790](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3790)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A wrist joint metal constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device prevents dislocation in more than one anatomic plane and consists of either a single flexible across-the-joint component or two components linked together. This generic type of device is limited to a device which is made of alloys, such as cobalt-chromium-molybdenum, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

## Classification Rationale

Class III.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYN](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYN)

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