

# NRA · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/NRA

## Overview

- **Product Code:** NRA
- **Device Name:** Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.  It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P010014](/device/P010014.md) | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | Biomet Manufacturing Corp | Apr 21, 2004 | APPR |
| [P910016](/device/P910016.md) | NEW JERSEY LCS(R) TOTAL KNEE SYSTEM | Depuy, Inc. | Oct 30, 1992 | APWD |

## Top Applicants

- Biomet Manufacturing Corp — 1 clearance
- Depuy, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/NRA](https://fda.innolitics.com/productcode/NRA)

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