# K042032: Maestro Total Wrist

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 7, 2004 after 71 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). 4 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031203: Biax a.F. Wrist/Biax Advanced Fixation Wrist, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K020554: Modification to Universal Total Wrist System, Kinetikos Medical, Inc. (2002) Summary page 1.
- K030037: Universal Total Wrist System, Kinetikos Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K200718: Arthrosurface WristMotion Total Wrist Arthroplasty System (2020), 0 descendants of its own

## Indications for use
The MaestroTM Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by: 1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis 2) Rheumatoid arthritis 3) Revision where other devices or treatments have failed 4) Scapholunate Advanced Collapse (SLAC) and other functional deformities 5) Trauma, including fractures of the distal radius and/or carpal bones The device is intended to be implanted with bone cement.

Source page: https://510kreport.com/device/K042032
Methodology: https://510kreport.com/methodology