# K233574: Total Wrist Arthroplasty System (TWA)

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics
- Decided: Jul 3, 2024 after 239 days
- Product code: JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961051 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021859: Wrist Implant, Avanta Orthopaedics, Inc. (2002) Summary page 4.
- (no number) Stryker Remotion Total Wrist Arthroplasty System: named in the summary without a submission number

## Most influential descendants
- K243381: Total Wrist Arthroplasty System (TWA) (2024), 0 descendants of its own

## Indications for use
The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

Source page: https://510kreport.com/device/K233574
Methodology: https://510kreport.com/methodology