Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3535](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3535) → NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

# NJD · Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

_Orthopedic · 21 CFR 888.3535 · Class 2_

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

## Overview

- **Product Code:** NJD
- **Device Name:** Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
- **Regulation:** [21 CFR 888.3535](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3535)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surface. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra-high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate.

## Classification Rationale

Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251975](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NJD/K251975.md) | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion | Sep 2, 2025 | SESE |
| [K242307](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NJD/K242307.md) | ACHIEVE Partial Knee System | Ignite Orthomotion | Dec 16, 2024 | SESE |
| [K222653](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NJD/K222653.md) | JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System | Smith+Nephew, Inc. | Oct 28, 2022 | SESE |
| [K190439](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NJD/K190439.md) | Engage™ Partial Knee System | Engage Uni, LLC | Nov 21, 2019 | SESE |
| [K133811](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NJD/K133811.md) | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corp. | Jul 8, 2014 | SESE |

## Top Applicants

- Ignite Orthomotion — 2 clearances
- Engage Uni, LLC — 1 clearance
- Mako Surgical Corp. — 1 clearance
- Smith+Nephew, Inc. — 1 clearance

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

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