# LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

- Device class: 2; regulation: 21 CFR 888.3360; FDA's rule: 510(k) required
- FDA decisions: 81
- Recalls: 22 (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)
- 2002: 1
- 2003: 6
- 2004: 1
- 2005: 4
- 2006: 2
- 2007: 2
- 2008: 1
- 2009: 1
- 2011: 1
- 2012: 1

## Most-cited predicates
- K042344: Excia Total Hip System (2005), cited by 17
- K050262: U2 Acetabular Component (2005), cited by 9
- K001942: SL-Plus and SLR-Plus Stems (2000), cited by 9
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert (2007), cited by 7
- K061699: EXCIA (2006), cited by 4
- K993601: Howmedica Osteonics Femoral Heads (1999), cited by 4
- K994126: Modular-Plus Revision Stem (2000), cited by 4
- K003016: Pro-Femur R (2000), cited by 3
- K994146: Epf-Plus Cementless Press-Fit Acetabular Cup (2000), cited by 3
- K873797: TI-Fit Total Hip System (1987), cited by 3

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