FDA product code KWM: Prosthesis, Wrist, Semi-Constrained
KWM is the FDA product code for prosthesis, wrist, semi-constrained. It is a Class II device, regulated under 21 CFR 888.3800 and reviewed by the Orthopedic panel. FDA has cleared 6 510(k) submissions under KWM, from 5 different applicants. The average 510(k) review took 165 days (median 94).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, Semi-Constrained |
| Device class | Class II |
| Regulation | 21 CFR 888.3800 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KWM clearance
Top KWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Depuy, Inc. | 2 | 1980-08-04 |
| Biomet, Inc. | 1 | 1988-02-17 |
| Protek, Inc. | 1 | 1987-07-23 |
| Laure Prosthetics, Inc. | 1 | 1982-06-29 |
| Dow Corning Wright | 1 | 1980-08-27 |
Most recent KWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880156 | Biomet, Inc. | VOLZ TOTAL WRIST PROSTHESIS | 1988-02-17 | 35 |
| K872502 | Protek, Inc. | M.W.P. WRIST PROSTHESIS | 1987-07-23 | 29 |
| K803031 | Laure Prosthetics, Inc. | LAURE WRIST IMPLANT | 1982-06-29 | 578 |
| K800602 | Dow Corning Wright | TALEISNIK TOTAL WRIST PROSTHESIS | 1980-08-27 | 163 |
| K801157 | Depuy, Inc. | WEBER-MAYO WRIST | 1980-08-04 | 82 |
Recalls for KWM devices
openFDA lists no recalls for product code KWM.
Frequently asked questions
What is FDA product code KWM?
KWM is the FDA product code for prosthesis, wrist, semi-constrained. It is a Class II device, regulated under 21 CFR 888.3800 and reviewed by the Orthopedic panel.
What device class is KWM?
Class II, regulation 21 CFR 888.3800. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWM?
Across 6 cleared submissions the average was 165 days from receipt to decision (median 94).
Which companies have the most KWM clearances?
Depuy, Inc. (2); Biomet, Inc. (1); Protek, Inc. (1); Laure Prosthetics, Inc. (1); Dow Corning Wright (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KWM
- Run a recall and safety report across every KWM manufacturer
- Watch product code KWM 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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