# KXE: Prosthesis, Wrist, Hemi-, Ulnar

- Device class: 2; regulation: 21 CFR 888.3810; FDA's rule: 510(k) required
- FDA decisions: 16
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1998: 1
- 2001: 1
- 2002: 1
- 2004: 2
- 2005: 3
- 2006: 1
- 2008: 2
- 2012: 1
- 2015: 1
- 2019: 1

## Most-cited predicates
- K010786: Ulnar Head Implant (2001), cited by 4
- K082839: Distal Radio-Ulnar Joint Implant (2008), cited by 2
- K040497: Distal Radio-Ulnar Joint Implant (2005), cited by 2
- K052137: Ascension Muh (2005), cited by 1
- K142569: Aptis Medical Distal Radio Ulnar Joint Implant (2015), cited by 1
- K053119: Distal Radio-Ulnar Joint Implant (2005), cited by 1

Source page: https://510kreport.com/product-code/KXE
Data by year (CSV): https://510kreport.com/product-code/KXE.csv