# JDL: Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

- Device class: 3; regulation: 21 CFR 888.3320; FDA's rule: PMA required
- FDA decisions: 45
- Recalls: 5 (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)
- 1992: 3
- 1993: 6
- 1994: 6
- 1995: 1
- 2001: 1
- 2004: 3
- 2005: 2
- 2006: 1
- 2007: 1
- 2008: 1

## Most-cited predicates
- K922561: Consensus (TM) Total Hip System (1993), cited by 11
- K070785: Dynasty Acetabular System (2007), cited by 4
- K004043: Metal Transcend Articulation System (2001), cited by 4
- K942809: Acetabular Dome Hole Plugs (1994), cited by 3
- K051995: Profemur Renaissance Hip Stem (2005), cited by 3
- K920868: Acetabular Dome and Screw Hole Plugs (1992), cited by 2
- K921139: Healey Revision Component System (1992), cited by 1
- K042841: M2A/C2A Acetabular System (2004), cited by 1
- K041114: Profemur Tapered Hip Stem (2004), cited by 1

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