JWJ
- Product code
- JWJ
- Device name
- Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3800
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 17
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243381 | 2024-11-01 | Skeletal Dynamics, Inc. | Total Wrist Arthroplasty System (TWA) | |
| K233574 | 2024-07-03 | Skeletal Dynamics | Total Wrist Arthroplasty System (TWA) | |
| K233674 | 2024-05-30 | Ascension Orthopedics, Inc. | Freedom Wrist Arthroplasty System |
Official FDA classification page: JWJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).