Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3180](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3180) → KWJ — Prosthesis, Elbow, Hemi-, Humeral, Metal

# KWJ · Prosthesis, Elbow, Hemi-, Humeral, Metal

_Orthopedic · 21 CFR 888.3180 · Class 3_

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

## Overview

- **Product Code:** KWJ
- **Device Name:** Prosthesis, Elbow, Hemi-, Humeral, Metal
- **Regulation:** [21 CFR 888.3180](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3180)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri. The generic type of device is limited to prostheses intended for use without 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/KWJ](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWJ)

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