# HSH: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

- Device class: 2; regulation: 21 CFR 888.3590; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 0 (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)
- 2001: 1
- 2002: 1
- 2003: 1
- 2006: 1
- 2008: 1

## Most-cited predicates
- K033242: Knee Interpositional Mini-Repair System (Kimrs) (2003), cited by 5
- K003269: Unicondylar Interpositional Spacer (2001), cited by 3
- K022779: Oti Unicondular Interpositional Spacer (2002), cited by 1
- K053094: Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056 (2006), cited by 1

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