MAY
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2015: 115 · 2016: 60 · 2017: 33 · 2018: 33 · 2020: 14 · 2021: 24
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 |
|---|---|---|
| ABG III MONOLITHIC HIP STEM (K123604) | Howmedica Osteonics Corp. | 2013-08-16 |
| ABG II MONOLITHIC HIP STEM (K110807) | Stryker Corp. | 2011-05-25 |
| 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL (K090103) | Biomet, Inc. | 2009-02-11 |
| EQUATOR PLUS ACETABULAR CUP SYSTEM (K051844) | Portland Orthopaedics Pty. , Ltd. | 2005-10-07 |
Track MAY automatically
Every clearance here is in the API, with alerts when new ones post.