FDA product code JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
JWH is the FDA product code for prosthesis, knee, patellofemorotibial, 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 921 510(k) submissions under JWH, 88 in the last five years, from 153 different applicants. The average 510(k) review took 135 days (median 90); 94 days on average over the last three years. FDA has posted 984 recalls for JWH devices, 134 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patellofemorotibial, 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 |
510(k) clearances per year for JWH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 25 | 151 |
| 2018 | 25 | 106 |
| 2019 | 28 | 151 |
| 2020 | 22 | 77 |
| 2021 | 24 | 94 |
| 2022 | 17 | 76 |
| 2023 | 20 | 85 |
| 2024 | 19 | 118 |
| 2025 | 20 | 74 |
| 2026 | 12 | 91 |
Compare with all 510(k) review times · Search every JWH clearance
Top JWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zimmer, Inc. | 51 | 2025-03-06 |
| Smith & Nephew, Inc. | 49 | 2025-04-02 |
| Howmedica Corp. | 47 | 1998-12-16 |
| Conformis, Inc. | 40 | 2023-07-17 |
| Biomet, Inc. | 40 | 2017-07-28 |
148 more applicants have JWH clearances. See the full list in Caduvo.
Most recent JWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262057 | Medacta International SA | GMK Extension | 2026-09-15 | 89 |
| K260063 | The General Hospital Corporation, d/b/a Massachusetts | GSPE Spacer | 2026-09-11 | 246 |
| K262293 | Suzhou Microport Orthorecon Co., Ltd. | EVOLUTION MPX Total Knee System | 2026-09-10 | 65 |
| K262341 | B-One Ortho, Corp. | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | 2026-09-08 | 60 |
| K262130 | Depuy Orthopaedics, Inc. | ATTUNE Revision Knee System | 2026-09-04 | 72 |
Recalls for JWH devices
984 product recalls in 287 recall events; 134 initiated in the last five years and 144 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2017 | 82 |
| 2018 | 30 |
| 2019 | 47 |
| 2020 | 26 |
| 2021 | 17 |
| 2022 | 23 |
| 2023 | 72 |
| 2024 | 17 |
| 2025 | 16 |
| 2026 | 6 |
Frequently asked questions
What is FDA product code JWH?
JWH is the FDA product code for prosthesis, knee, patellofemorotibial, 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 JWH?
Class II, regulation 21 CFR 888.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code JWH?
Across 921 cleared submissions the average was 135 days from receipt to decision (median 90).
Which companies have the most JWH clearances?
Zimmer, Inc. (51); Smith & Nephew, Inc. (49); Howmedica Corp. (47); Conformis, Inc. (40); Biomet, Inc. (40).
Have JWH devices been recalled?
Yes: 984 product recalls across 287 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JWH
- Run a recall and safety report across every JWH manufacturer
- Watch product code JWH 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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