NJD · Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Orthopedic · 21 CFR 888.3535 · Class 2
Overview
| Product Code | NJD |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
| Regulation | 21 CFR 888.3535 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion | Sep 2, 2025 | SESE |
| K242307 | ACHIEVE Partial Knee System | Ignite Orthomotion | Dec 16, 2024 | SESE |
| K222653 | JOURNEY II UK and ENGAGE Cementless Partial Knee System | Smith+Nephew, Inc. | Oct 28, 2022 | SESE |
| K190439 | Engage Partial Knee System | Engage Uni, LLC | Nov 21, 2019 | SESE |
| K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corp. | Jul 8, 2014 | SESE |
Top Applicants
- Ignite Orthomotion — 2 clearances
- Smith+Nephew, Inc. — 1 clearance
- Mako Surgical Corp. — 1 clearance
- Engage Uni, LLC — 1 clearance
