# K132250: Integra Freedom Wrist Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Mar 24, 2014 after 248 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: 4 generations back to K961051 (1996). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030037: Universal Total Wrist System, Kinetikos Medical, Inc. (2003) Summary page 1.
- K042032: Maestro Total Wrist, Biomet, Inc. (2004) Summary page 1.

## Most influential descendants
- K233674: Freedom Wrist Arthroplasty System (2024), 0 descendants of its own
- K191525: KinematX Total Wrist Arthroplasty System (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K132250
Methodology: https://510kreport.com/methodology