# OYK: Ankle Arthroplasty Implantation System

- Device class: 2; regulation: 21 CFR 888.3110; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 71 days (middle half 26–123)
- 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)
- 2020: 1
- 2023: 2
- 2024: 4

## Most-cited predicates
- K193432: Vantage PSI System (2020), cited by 4
- K241326: Cadence Ankle PSI System (2024), cited by 1
- K241148: Salto Talaris Ankle PSI System (2024), cited by 1

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