# HXK: Holder, Needle; Orthopedic

- Device class: 1; regulation: 21 CFR 888.4540; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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)
- 1978: 1
- 1980: 1
- 1986: 1
- 1987: 1
- 1989: 1

## Most-cited predicates
- K801594: Ace Fischer External Fixation Device (1980), cited by 1
- K860018: Fischer Wire/Pin Clamp (1986), cited by 1

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