HTG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3580
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2009: 153 · 2010: 147 · 2011: 123 · 2012: 54 · 2013: 39 · 2014: 13
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 |
|---|---|---|
| PATELLAR COMPONENT FOR LUBINUS PATELLAR (K800800) | Waldemar Link GmbH & Co. KG | 1980-04-21 |
| WORRELL PATELLA (K771708) | Depuy, Inc. | 1977-10-06 |
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Every clearance here is in the API, with alerts when new ones post.