# KIJ: Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

- Device class: 1; regulation: 21 CFR 878.4820; FDA's rule: 510(k) exempt
- FDA decisions: 29
- Recalls: 10 (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: 3
- 1986: 1
- 1988: 2
- 1994: 5
- 1995: 2
- 1996: 1
- 1997: 2
- 2010: 1
- 2012: 1
- 2016: 1

## Most-cited predicates
- K771218: Intra-Articular Shaver (1978), cited by 7
- K820367: Intra-Articular Surgical System (1982), cited by 3
- K933101: The Osteomed B Power System and Accessories (1994), cited by 3
- K972367: Stryker System 4000 Heavy Duty Battery Powered Equipment (1997), cited by 2
- K932307: 3M Maxi-Driver II Dbattery Powered System (1994), cited by 1
- K112599: Insurgical Single Use Power Equipment (2012), cited by 1
- K101563: Smarto (2010), cited by 1

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