FDA product code NJD: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
NJD is the FDA product code for prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3535 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under NJD, 3 in the last five years, from 4 different applicants. The average 510(k) review took 146 days (median 133); 100 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3535 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NJD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 269 |
| 2022 | 1 | 57 |
| 2024 | 1 | 133 |
| 2025 | 1 | 68 |
Compare with all 510(k) review times · Search every NJD clearance
Top NJD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ignite Orthomotion | 2 | 2025-09-02 |
| Smith+Nephew, Inc. | 1 | 2022-10-28 |
| Engage Uni, LLC | 1 | 2019-11-21 |
| Mako Surgical Corp. | 1 | 2014-07-08 |
Most recent NJD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251975 | Ignite Orthomotion | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | 2025-09-02 | 68 |
| K242307 | Ignite Orthomotion | ACHIEVE Partial Knee System | 2024-12-16 | 133 |
| K222653 | Smith+Nephew, Inc. | JOURNEY II UK and ENGAGE Cementless Partial Knee System | 2022-10-28 | 57 |
| K190439 | Engage Uni, LLC | Engage Partial Knee System | 2019-11-21 | 269 |
| K133811 | Mako Surgical Corp. | RESTORIS POROUS PARTIAL KNEE SYSTEM | 2014-07-08 | 204 |
Recalls for NJD devices
openFDA lists no recalls for product code NJD.
Frequently asked questions
What is FDA product code NJD?
NJD is the FDA product code for prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3535 and reviewed by the Orthopedic panel.
What device class is NJD?
Class II, regulation 21 CFR 888.3535. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJD?
Across 5 cleared submissions the average was 146 days from receipt to decision (median 133).
Which companies have the most NJD clearances?
Ignite Orthomotion (2); Smith+Nephew, Inc. (1); Engage Uni, LLC (1); Mako Surgical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJD
- Run a recall and safety report across every NJD manufacturer
- Watch product code NJD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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