# KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

- Device class: 2; regulation: 21 CFR 888.3390; FDA's rule: 510(k) required
- FDA decisions: 99
- 510(k) review time 2021–2025: median 129 days (middle half 29–207)
- Recalls: 64 (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)
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 5
- 2020: 1
- 2022: 2
- 2023: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K123991: Depuy Corail Amt Hip Prosthesis (2013), cited by 11
- K003363: M2A 32MM Taper System (2000), cited by 7
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60) (2009), cited by 6
- K982447: Plus Bipolar Prosthesis Cocrmo (1998), cited by 5
- K991990: Tri-Polar System (1999), cited by 5
- K023743: Smith & Nephew Global Bipolar System (2003), cited by 5
- K082705: Biopro Bipolar Head, Models 18130-18152 (2008), cited by 4
- K812672: Self-Centering Hip (1981), cited by 4
- K931655: P.F.C. Bipolar Hip System (1994), cited by 4
- K060707: Aesculap Bipolar Acetabular Cup (2006), cited by 4

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