NJD
5 FDA 510(k) clearances · Product code
133 daysmedian time to decision
269 days90th percentile
5clearances measured
FDA profile
- Official device name
- Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3535
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA 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.
- Adverse events (MAUDE)
- 2022: 34 · 2023: 61
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (K251975) | Ignite Orthomotion | 2025-09-02 |
| ACHIEVE Partial Knee System (K242307) | Ignite Orthomotion | 2024-12-16 |
| JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (K222653) | Smith+Nephew, Inc. | 2022-10-28 |
| Engage™ Partial Knee System (K190439) | Engage Uni, LLC | 2019-11-21 |
| RESTORIS POROUS PARTIAL KNEE SYSTEM (K133811) | Mako Surgical Corp. | 2014-07-08 |
Track NJD automatically
Every clearance here is in the API, with alerts when new ones post.