# KWA: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

- Device class: 3; regulation: 21 CFR 888.3330; FDA's rule: PMA required
- FDA decisions: 114
- Recalls: 172 (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)
- 2003: 1
- 2004: 6
- 2005: 8
- 2006: 11
- 2007: 8
- 2008: 9
- 2009: 7
- 2010: 6
- 2011: 11
- 2012: 4

## Most-cited predicates
- K060358: Profemur TL Hip Stem (2006), cited by 9
- K091423: Profemur Hip System Modular Necks (2009), cited by 9
- K101086: Taperloc Complete (2010), cited by 9
- K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner (2009), cited by 9
- K110400: Taperloc Complete Microplasty Stem (2011), cited by 9
- K071723: Zimmer Porolock Mis Stem (2008), cited by 8
- K103755: Taperloc Complete, Size 5 and 6 (2011), cited by 8
- K042037: M2A Magnum System (2004), cited by 8
- K993438: Metal on Metal Acetabular System (2000), cited by 7
- K090757: Biomet Modular Femoral Revision System (2009), cited by 7

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