# K233674: Freedom Wrist Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: May 30, 2024 after 196 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: 5 generations back to K961051 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132250: Integra Freedom Wrist Arthroplasty System, Integra LifeSciences Corporation (2014) Summary page 4.

## Indications for use
The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.

Source page: https://510kreport.com/device/K233674
Methodology: https://510kreport.com/methodology