# KWN: Prosthesis, Wrist, Carpal Lunate

- Device class: 2; regulation: 21 CFR 888.3750; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 0 (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)
- 1979: 1
- 1987: 1
- 2005: 1
- 2008: 1
- 2014: 1

## Most-cited predicates
- K864491: Swanson Titanium Carpal Lunate Implant (1987), cited by 3
- K050028: Maestro Carpal Hemiarthroplasty (2005), cited by 2
- K141920: Wrist Hemiarthroplasty System (2014), cited by 1
- K080997: Ascension Pyrocarbon Lunate (2008), cited by 1

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