# K141920: Wrist Hemiarthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Dec 23, 2014 after 160 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: 5 generations back to K961051 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050028: Maestro Carpal Hemiarthroplasty, Biomet Manufacturing, Inc. (2005) Summary page 5.

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

## Indications for use
Indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by: Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis Rheumatoid arthritis Revision where other devices or treatments have failed Scapholunate Advanced Collapse (SLAC) and other functional deformities Trauma, including fractures of the carpal bones The device is a single use implant intended to be used with bone cement.

Source page: https://510kreport.com/device/K141920
Methodology: https://510kreport.com/methodology