FDA product code JWJ: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
JWJ is the FDA product code for prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained. It is a Class II device, regulated under 21 CFR 888.3800 and reviewed by the Orthopedic panel. FDA has cleared 17 510(k) submissions under JWJ, 3 in the last five years, from 15 different applicants. The average 510(k) review took 148 days (median 89); 146 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal 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 |
510(k) clearances per year for JWJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 239 |
| 2024 | 3 | 146 |
Top JWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetikos Medical, Inc. | 3 | 2003-02-05 |
| Skeletal Dynamics, Inc. | 1 | 2024-11-01 |
| Skeletal Dynamics | 1 | 2024-07-03 |
| Ascension Orthopedics, Inc. | 1 | 2024-05-30 |
| Arthrosurface, Inc. | 1 | 2020-10-15 |
10 more applicants have JWJ clearances. See the full list in Caduvo.
Most recent JWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243381 | Skeletal Dynamics, Inc. | Total Wrist Arthroplasty System (TWA) | 2024-11-01 | 2 |
| K233574 | Skeletal Dynamics | Total Wrist Arthroplasty System (TWA) | 2024-07-03 | 239 |
| K233674 | Ascension Orthopedics, Inc. | Freedom Wrist Arthroplasty System | 2024-05-30 | 196 |
| K200718 | Arthrosurface, Inc. | Arthrosurface WristMotion Total Wrist Arthroplasty System | 2020-10-15 | 210 |
| K191525 | Extremity Medical, LLC | KinematX Total Wrist Arthroplasty System | 2020-03-04 | 268 |
Recalls for JWJ devices
openFDA lists no recalls for product code JWJ.
Frequently asked questions
What is FDA product code JWJ?
JWJ is the FDA product code for prosthesis, wrist, 3 part metal-plastic-metal 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 JWJ?
Class II, regulation 21 CFR 888.3800. Typical premarket route: 510(k).
How long does a 510(k) take for product code JWJ?
Across 17 cleared submissions the average was 148 days from receipt to decision (median 89).
Which companies have the most JWJ clearances?
Kinetikos Medical, Inc. (3); Skeletal Dynamics, Inc. (1); Skeletal Dynamics (1); Ascension Orthopedics, Inc. (1); Arthrosurface, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JWJ
- Run a recall and safety report across every JWJ manufacturer
- Watch product code JWJ 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.