Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3640](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3640) → KWR — Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

# KWR · Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

_Orthopedic · 21 CFR 888.3640 · Class 3_

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

## Overview

- **Product Code:** KWR
- **Device Name:** Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
- **Regulation:** [21 CFR 888.3640](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3640)
- **Device Class:** 3
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid component made of this alloy or a combination of this alloy and ultra-high molecular weight polyethylene. This generic type of device 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/KWR](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWR)

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