# HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

- Device class: 1; regulation: 21 CFR 878.4820; FDA's rule: 510(k) exempt
- FDA decisions: 76
- Recalls: 21 (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)
- 1994: 17
- 1995: 7
- 1996: 11
- 1997: 9
- 1999: 1
- 2002: 3
- 2005: 2
- 2007: 1
- 2011: 1
- 2015: 1

## Most-cited predicates
- K943589: Stryker Total Performance System (1994), cited by 5
- K970088: Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1: (1997), cited by 4
- K895198: Hall Versipower Surgical Instrument System (1989), cited by 3
- K935567: Sodem Power System (1994), cited by 3
- K962913: Synthes Sterile Drill Bits (1996), cited by 3
- K043310: Synthes (Usa) Electric Pen Drive System (2005), cited by 3
- K880150: Pacesetter (TM) 3500 Arthroscopic Surgical System (1988), cited by 2
- K143191: IntelliSense Drill (2015), cited by 1
- K942956: Surgical Instruments and Accessories (1994), cited by 1
- K942660: Hall Microchoice Electric Powered System (1994), cited by 1

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