# HSZ: Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

- Device class: 1; regulation: 21 CFR 878.4820; FDA's rule: 510(k) exempt
- FDA decisions: 56
- Recalls: 2 (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)
- 1989: 3
- 1990: 5
- 1991: 4
- 1992: 3
- 1993: 3
- 1994: 5
- 1995: 3
- 1996: 1
- 1997: 2
- 1999: 1

## Most-cited predicates
- K844131: Nucleotome (1984), cited by 2
- K831756: Anspach 65,000 (1983), cited by 2
- K885229: Modified Glenoid Arcuate Drill & Disp. Flexi-Bits (1989), cited by 1
- K880074: Rsi Glenoid Arcuate Bone Drill W/Disp. Flexi-Bits (1988), cited by 1
- K926547: Mednext 1000 Bone Dissecting System (1993), cited by 1

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