# HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3110; FDA's rule: 510(k) required
- FDA decisions: 69
- 510(k) review time 2021–2025: median 95 days (middle half 58–163)
- Recalls: 13 (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)
- 2017: 4
- 2018: 4
- 2019: 2
- 2020: 6
- 2021: 4
- 2022: 1
- 2023: 6
- 2024: 7
- 2025: 3
- 2026: 2

## Most-cited predicates
- K123954: Infinity Total Ankle System (2013), cited by 11
- K140749: Infinity Total Ankle System (2014), cited by 9
- K051023: Topez Total Ankle Replacement (2005), cited by 9
- K100886: Inbone II Total Ankle Replacement (2010), cited by 8
- K020541: Agility Ankle Revision Prosthesis (2002), cited by 6
- K920802: Alvine Total Ankle (1992), cited by 6
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), cited by 5
- K090076: Salto Talaris Total Ankle Prosthesis (2009), cited by 5
- K060544: Salto Talaris Total Ankle Prosthesis (2006), cited by 5
- K152217: Exactech Vantage Total Ankle System (2016), cited by 5

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