# K030037: Universal Total Wrist System

- Pathway: 510(k) (Special)
- Applicant: Kinetikos Medical, Inc.
- Decided: Feb 5, 2003 after 30 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.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961051: Universal Total Wrist System (Modification), Kinetikos Medical, Inc. (1996) Summary page 1.
- K020554: Modification to Universal Total Wrist System, Kinetikos Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K042032: Maestro Total Wrist (2004), 7 descendants of its own
- K050028: Maestro Carpal Hemiarthroplasty (2005), 3 descendants of its own
- K132250: Integra Freedom Wrist Arthroplasty System (2014), 2 descendants of its own
- K141920: Wrist Hemiarthroplasty System (2014), 1 descendant of its own
- K233674: Freedom Wrist Arthroplasty System (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K030037
Methodology: https://510kreport.com/methodology