# OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

- Device class: 2; regulation: 21 CFR 888.3560; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 58 days (middle half 58–58)
- Recalls: 2 (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)
- 2010: 4
- 2011: 2
- 2012: 2
- 2013: 1
- 2020: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K101433: Depuy Attune Knee System (2010), cited by 15
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 (2010), cited by 9
- K111433: Depuy Sttune (TM) PS Knee System (2011), cited by 8
- K100048: E1 Antioxidant Infused Technology (2010), cited by 5
- K103756: Depuy Attune Total Knee System (2011), cited by 3
- K121727: Movation Knee System (2012), cited by 3
- K120038: A200 Knee System (2013), cited by 2
- K113756: Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA (2012), cited by 2
- K103223: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts (2010), cited by 2

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