# JDK: Prosthesis, Hip, Cement Restrictor

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 54
- 510(k) review time 2021–2025: median 87 days (middle half 87–87)
- 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)
- 1994: 1
- 1997: 1
- 1999: 1
- 2001: 9
- 2002: 8
- 2003: 9
- 2004: 3
- 2005: 6
- 2006: 4
- 2021: 1

## Most-cited predicates
- K990345: Rabea Device, Model Pxxxxxx (1999), cited by 6
- K003718: Titanium Cement Restrictor (TCR) (2001), cited by 6
- K013014: Block Cement Restrictor (CR) - Titanium (2001), cited by 4
- K021719: Fortitude Cement Restrictor (2002), cited by 4
- K031837: Modification to Fortitude Cement Restrictor (2003), cited by 4
- K013663: Cement Restrictor (2001), cited by 3
- K010528: Titanium Cement Restrictor Material Peek (2001), cited by 3
- K022218: Cadence Cement Restrictor (2002), cited by 3
- K020836: Rabea Cement Restrictor (2002), cited by 3
- K040276: Quantum Cement Restrictor (2004), cited by 2

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