Panels › Orthopedic › Product code NJD · Class 2
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Regulation 888.3535
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NJD
| Company | 510(k)s | Recalls |
|---|---|---|
| Ignite Orthomotion | 2 | 0 |
| Engage Uni, LLC | 1 | 0 |
| Mako Surgical Corp. | 1 | 0 |
| Smith+Nephew, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2025 | K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component Ignite Orthomotion | NJD |
| Dec 16, 2024 | K242307 | ACHIEVE Partial Knee System Ignite Orthomotion | NJD |
| Oct 28, 2022 | K222653 | JOURNEY II UK and ENGAGE Cementless Partial Knee System Smith+Nephew, Inc. | NJD |
| Nov 21, 2019 | K190439 | Engage Partial Knee System Engage Uni, LLC | NJD |
| Jul 8, 2014 | K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM Mako Surgical Corp. | NJD |
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