# NJL · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

_ ·  · Class 3_

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

## Overview

- **Product Code:** NJL
- **Device Name:** Prosthesis, Knee, Patellofemorotibial, 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 bearing and metal baseplate components of a knee prosthesis.  It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P060037](/device/P060037.md) | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM | Zimmer, Inc. | Dec 10, 2007 | APPR |
| [P830055](/device/P830055.md) | LCS(R) TOTAL KNEE SYSTEM | Depuy, Inc. | Apr 12, 1985 | APPR |

## Top Applicants

- Depuy, Inc. — 1 clearance
- Zimmer, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com