# KMC: Prosthesis, Hip, Semi-Constrained,  Composite/Metal

- Device class: 2; regulation: 21 CFR 888.3340; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 1985: 2
- 1994: 1

## Most-cited predicates

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