# KXA: Prosthesis, Hip, Femoral, Resurfacing

- Device class: 2; regulation: 21 CFR 888.3400; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 258 days (middle half 258–258)
- Recalls: 16 (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)
- 1998: 1
- 2000: 1
- 2002: 3
- 2003: 1
- 2005: 1
- 2006: 1
- 2007: 2
- 2008: 1
- 2010: 1
- 2021: 1

## Most-cited predicates
- K994153: Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis (2000), cited by 4
- K021799: Cemented Femoral Head Resurfing Device (2002), cited by 3
- K023188: Press-Fit Head Resurfacing Device (2002), cited by 3
- K032659: Depuy Asr Resurfacing Femoral Heads (2003), cited by 2
- K983452: Nelson Resurfacing Head (1998), cited by 2
- K062960: Conserve Femoral Resurfacing Component (2006), cited by 2
- K082673: Conserve Pressfit Femoral Component (2008), cited by 1
- K892398: Bipolar Hip System (1989), cited by 1
- K071053: Recap HA Press-Fit Femoral Resurfacing Head (2007), cited by 1
- K043542: Biopro Tara Femoral Resurfacing Component (2005), cited by 1

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