FDA product code NPJ: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NPJ is the FDA product code for prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel. FDA has cleared 12 510(k) submissions under NPJ, from 6 different applicants. The average 510(k) review took 73 days (median 80). FDA has posted 9 recalls for NPJ devices, 1 initiated in the last five years.
Definition
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NPJ clearance
Top NPJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 4 | 2009-12-15 |
| Mako Surgical Corporation | 2 | 2013-12-10 |
| Conformis, Inc. | 2 | 2009-12-16 |
| DePuy Orthopaedics, Inc. | 2 | 2007-06-26 |
| Mako Surgical Corp. | 1 | 2015-03-10 |
1 more applicants have NPJ clearances. See the full list in Caduvo.
Most recent NPJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150307 | Mako Surgical Corp. | RESTORIS Multicompartmental Knee System | 2015-03-10 | 29 |
| K133039 | Mako Surgical Corporation | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | 2013-12-10 | 75 |
| K093513 | Conformis, Inc. | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | 2009-12-16 | 33 |
| K093056 | Smith & Nephew, Inc. | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | 2009-12-15 | 76 |
| K090763 | Mako Surgical Corporation | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | 2009-06-17 | 86 |
Recalls for NPJ devices
9 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NPJ?
NPJ is the FDA product code for prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel.
What device class is NPJ?
Class II, regulation 21 CFR 888.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPJ?
Across 12 cleared submissions the average was 73 days from receipt to decision (median 80).
Which companies have the most NPJ clearances?
Smith & Nephew, Inc. (4); Mako Surgical Corporation (2); Conformis, Inc. (2); DePuy Orthopaedics, Inc. (2); Mako Surgical Corp. (1).
Have NPJ devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code NPJ
- Run a recall and safety report across every NPJ manufacturer
- Watch product code NPJ 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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