# HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3520; FDA's rule: 510(k) required
- FDA decisions: 115
- 510(k) review time 2021–2025: median 72 days (middle half 57–208)
- Recalls: 60 (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: 5
- 2018: 2
- 2019: 7
- 2020: 4
- 2021: 7
- 2022: 2
- 2023: 1
- 2024: 4
- 2025: 4
- 2026: 2

## Most-cited predicates
- K033363: Zimmer Unicompartmental Knee System (2004), cited by 22
- K102069: Journey Unicondylar Tibial Baseplates (2010), cited by 9
- K912735: Genesis Unicompartmental Knee System (1991), cited by 9
- K043570: Unicondylar Knee Repair System / Conformis Ucd (2005), cited by 9
- K073175: Journey Unicondylar Femoral Implant (2007), cited by 7
- K033769: Eius Unicompartmental Knee System (2004), cited by 7
- K954186: Sled Unicompartment Knee System (1996), cited by 6
- K880155: Miller/Galante Precoat Unicompartmental Knee (1988), cited by 5
- K010685: Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface) (2001), cited by 5
- K060670: Accin Uni-Knee System (2006), cited by 5

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