# K191525: KinematX Total Wrist Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Mar 4, 2020 after 268 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042032: Maestro Total Wrist, Biomet, Inc. (2004) Summary page 4.
- K132250: Integra Freedom Wrist Arthroplasty System, Integra LifeSciences Corporation (2014) Summary page 4.
- K021859: Wrist Implant, Avanta Orthopaedics, Inc. (2002) Summary page 4.

## Indications for use
The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by: 1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease 2. Revision where other devices or treatments have failed 3. Scapholunate Advanced Collapse (SLAC) 4. Rheumatoid Arthritis The device is intended to be implanted with bone cement.

Source page: https://510kreport.com/device/K191525
Methodology: https://510kreport.com/methodology