# HXA: Prosthesis, Tendon, Passive

- Device class: 2; regulation: 21 CFR 888.3025; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 63 days (middle half 63–63)
- Recalls: 0 (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: 2
- 1985: 1
- 1987: 3
- 1993: 1
- 1997: 2
- 2000: 1
- 2025: 1

## Most-cited predicates
- K000019: Single Size Tendon Spacer (2000), cited by 2
- K964359: Avanta Orthopaedics Tendon Spacer (1997), cited by 1

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