# K243381: Total Wrist Arthroplasty System (TWA)

- Pathway: 510(k) (Special)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Nov 1, 2024 after 2 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: 3 generations back to K961051 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233574: Total Wrist Arthroplasty System (TWA), Skeletal Dynamics (2024) Summary page 5.

## 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/K243381
Methodology: https://510kreport.com/methodology