# HXI: Passer, Wire, Orthopedic

- Device class: 1; regulation: 21 CFR 888.4540; FDA's rule: 510(k) exempt
- FDA decisions: 3
- Recalls: 7 (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: 2
- 2014: 1

## Most-cited predicates

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