NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class II
Classification Details
- Product Code
- NJD
- Device Class
- Class II
- Regulation Number
- 888.3535
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251975 | ignite orthomotion | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | September 2, 2025 |
| K242307 | ignite orthomotion | ACHIEVE Partial Knee System | December 16, 2024 |
| K222653 | smith+nephew | JOURNEY II UK and ENGAGE Cementless Partial Knee System | October 28, 2022 |
| K190439 | engage uni | Engage Partial Knee System | November 21, 2019 |
| K133811 | mako surgical | RESTORIS POROUS PARTIAL KNEE SYSTEM | July 8, 2014 |