# NPJ: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3560; FDA's rule: 510(k) required
- FDA decisions: 12
- Recalls: 7 (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)
- 2005: 3
- 2006: 3
- 2007: 1
- 2009: 3
- 2013: 1
- 2015: 1

## Most-cited predicates
- K061648: Depuy Graduated Compartmental Knee (GCK) (2006), cited by 6
- K052917: Stryker Compartmental Knee System (2005), cited by 5
- K053488: Conformis Bicompartmental Knee Repair System (2006), cited by 5
- K070849: Depuy GCK Femoral and Tibial Components (2007), cited by 4
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), cited by 4
- K042896: Smith & Nephew Hybrid Knee Femoral (2005), cited by 3
- K093513: Iduo Bicompartmental Knee Repair System (2009), cited by 2
- K150307: RESTORIS Multicompartmental Knee System (2015), cited by 2
- K061569: Smith & Nephew Competitor Deuce Femoral Components (2006), cited by 1
- K052265: Smith & Nephew Competitor Duo Knee Femoral (2005), cited by 1

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