HSH
5 FDA 510(k) clearances · Product code
85 daysmedian time to decision
95 days90th percentile
5clearances measured
FDA profile
- Official device name
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3590
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2010: 543 · 2011: 21 · 2012: 79 · 2013: 37 · 2014: 16 · 2015: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS (K073233) | Advanced Bio-Surfaces, Inc. | 2008-01-28 |
| ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 (K053094) | Advanced Bio-Surfaces, Inc. | 2006-02-06 |
| KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) (K033242) | Imaging Therapeutics, Inc. | 2003-12-31 |
| OTI UNICONDULAR INTERPOSITIONAL SPACER (K022779) | Osteoimplant Technology, Inc. | 2002-11-20 |
| UNICONDYLAR INTERPOSITIONAL SPACER (K003269) | Sulzer Orthopedics, Inc. | 2001-01-04 |
Track HSH automatically
Every clearance here is in the API, with alerts when new ones post.