# HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3530; FDA's rule: 510(k) required
- FDA decisions: 92
- Recalls: 22 (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
- 2010: 1
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K971938: Repicci II Unicondylar Knee (1997), cited by 14
- K010810: Depuy Preservation Unicondylar Knee Prosthesis (2001), cited by 8
- K012591: Advance Unicondylar Knee System (2001), cited by 7
- K980665: Repicci II Unicondylar Knee All Poly Tibial Components (1998), cited by 7
- K110415: Signature Planner / Signature Guides (2011), cited by 4
- K040268: Depuy Preservation Unicondylar Tibia (2004), cited by 4
- K020741: Unicondylar Knee (2002), cited by 4
- K022437: Uni Knee (2002), cited by 4
- K071881: Triathlon PKR System (2007), cited by 3
- K982859: UC-Plus Solution Unicondylar Knee System (1999), cited by 3

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