# K050028: Maestro Carpal Hemiarthroplasty

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Mar 25, 2005 after 78 days
- Product code: KWN (Prosthesis, Wrist, Carpal Lunate)
- Device class: 2
- Regulation: 21 CFR 888.3750
- 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). 7 ancestors in all.
3 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)
- K864490: Swanson Titanium Carpal Scaphoid Implant, Dow Corning Wright (1987) Summary page 1.
- K864491: Swanson Titanium Carpal Lunate Implant, Dow Corning Wright (1987) Summary page 1.
- K042032: Maestro Total Wrist, Biomet, Inc. (2004) Summary page 1.

## Most influential descendants
- K141920: Wrist Hemiarthroplasty System (2014), 1 descendant of its own
- K200718: Arthrosurface WristMotion Total Wrist Arthroplasty System (2020), 0 descendants of its own
- K080426: Maestro Wrist Fracture Implant (2008), 0 descendants of its own

## Indications for use
The MaestroTM Carpal HemiArthroplasty 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 carpal bones The device is intended to be implanted with bone cement.

Source page: https://510kreport.com/device/K050028
Methodology: https://510kreport.com/methodology