# KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3540; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 67 days (middle half 52–163)
- 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)
- 2008: 3
- 2012: 1
- 2013: 1
- 2015: 1
- 2016: 1
- 2018: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K041160: Avon Extra-Small Patello-Femoral Replacement (2004), cited by 5
- K020841: Avon Patellar Component (2002), cited by 4
- K073120: Accin Patellofemoral System (2008), cited by 4
- K060127: Hemicap Patello-Femoral Resurfacing Prosthesis (2006), cited by 4
- K051948: Avon Patello-Femoral Joint Prosthesis (2005), cited by 4
- K051086: Smith & Nephew Patello-Femoral Implant (2005), cited by 4
- K080029: Mako Surgical Corp. Patellofemoral Knee Implant System (2008), cited by 3
- K010100: Avon Patello-Femoral Joint Prosthesis (2001), cited by 3
- K070695: Zimmer Patellofemoral Joint Prosthesis (2007), cited by 3
- K002356: Natural-Knee II Patellofemoral Joint Prosthesis (2000), cited by 2

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