# K080426: Maestro Wrist Fracture Implant

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jul 29, 2008 after 160 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 1.
- K050028: Maestro Carpal Hemiarthroplasty, Biomet Manufacturing, Inc. (2005) Summary page 1.

## Indications for use
The Maestro TM 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 (SLAG) and other functional deformities. 5) Trauma, including fractures of the distal radius and/or carpal bones. The radial and carpal components are intended to be implanted with bone cement.

Source page: https://510kreport.com/device/K080426
Methodology: https://510kreport.com/methodology