# KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3310; FDA's rule: 510(k) required
- FDA decisions: 36
- 510(k) review time 2021–2025: median 232 days (middle half 130–333)
- Recalls: 11 (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)
- 2007: 7
- 2008: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2016: 1
- 2017: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- P960047: Osteonics Constrained Acetabular Insert (1997), cited by 6
- P960054: S-Rom Poly-Dial Constrained Liner (1997), cited by 6
- K033442: Reflection Constrained Liner (2003), cited by 6
- K021803: Reflection Constrained Liner (2002), cited by 5
- K030047: Freedom Constrained Liners (2003), cited by 4
- K030923: Epsilon Durasul Constrained Acetabular Liner (2003), cited by 4
- K071718: Trilogy Longevity Constrained Liner (2007), cited by 3
- K083566: R3 Constrained Liner, Constrained Liner (2009), cited by 3
- K061654: Trident Constrained Acetabular Insert (2006), cited by 3
- K052079: Pinnacle Constrained Acetabular Liners (2005), cited by 3

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