# KMW: Handpiece, Rotary Bone Cutting

- Device class: 2; regulation: 21 CFR 872.4120; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 87 days (middle half 87–87)
- Recalls: 9 (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)
- 1986: 1
- 1994: 1
- 1997: 2
- 2000: 1
- 2008: 1
- 2017: 2
- 2021: 1

## Most-cited predicates
- K970953: E-Type Speed Reducer Contra Angle (1997), cited by 3
- K080939: Surgical Handpieces, Mikro Saw Handpieces (2008), cited by 2
- K971692: Osteopower System and Accessories (1997), cited by 1

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