# JDG: Prosthesis, Hip, Femoral Component, Cemented, Metal

- Device class: 2; regulation: 21 CFR 888.3360; FDA's rule: 510(k) required
- FDA decisions: 59
- 510(k) review time 2021–2025: median 187 days (middle half 187–187)
- Recalls: 9 (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)
- 1991: 1
- 1993: 5
- 1994: 6
- 1995: 4
- 1996: 2
- 1999: 1
- 2000: 1
- 2018: 1
- 2020: 1
- 2022: 1

## Most-cited predicates
- K992234: The Taper-Fit Total Hip System (1999), cited by 4
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), cited by 4
- K942027: Impact CO-CR 1-Piece Femoral Component (1994), cited by 2
- K942028: RX90 Femoral Component (1994), cited by 2
- K915787: Stability Hip Stem with Porocoat (1993), cited by 2
- K942479: Integral CO-CR Femoral Component (1994), cited by 1
- K874868: Opti-Fix Collared Femoral Components (1988), cited by 1
- K193546: Distal Centralizers (2020), cited by 1
- K001984: Progeny Forged Cocr Cemented Femoral Component (2000), cited by 1

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