FDA product code JWI: Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
JWI is the FDA product code for prosthesis, wrist, 2 part metal-plastic articulation, semi-constrained. It is a Class II device, regulated under 21 CFR 888.3800 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under JWI, from 3 different applicants. The average 510(k) review took 402 days (median 381).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, 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 JWI clearance
Top JWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ferguson Medical | 1 | 1995-05-22 |
| Turnkey Intergration USA, Inc. | 1 | 1995-02-06 |
| Meridian Diagnostics, Inc. | 1 | 1980-01-17 |
Most recent JWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931265 | Ferguson Medical | FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND | 1995-05-22 | 805 |
| K940297 | Turnkey Intergration USA, Inc. | UNIVERSAL WRIST | 1995-02-06 | 381 |
| K792687 | Meridian Diagnostics, Inc. | ASPERGILLUS SP., ANTIGEN | 1980-01-17 | 21 |
Recalls for JWI devices
openFDA lists no recalls for product code JWI.
Frequently asked questions
What is FDA product code JWI?
JWI is the FDA product code for prosthesis, wrist, 2 part metal-plastic articulation, semi-constrained. It is a Class II device, regulated under 21 CFR 888.3800 and reviewed by the Orthopedic panel.
What device class is JWI?
Class II, regulation 21 CFR 888.3800. Typical premarket route: 510(k).
How long does a 510(k) take for product code JWI?
Across 3 cleared submissions the average was 402 days from receipt to decision (median 381).
Which companies have the most JWI clearances?
Ferguson Medical (1); Turnkey Intergration USA, Inc. (1); Meridian Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JWI
- Run a recall and safety report across every JWI manufacturer
- Watch product code JWI 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times