MJT
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
- Device class
- Class III (high risk)
- Medical specialty
- Unknown
- Flags
- Implant
- Adverse events (MAUDE)
- 2001: 2 · 2002: 3 · 2004: 2 · 2016: 11 · 2017: 26 · 2018: 39
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 |
|---|---|---|
| OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM (K990712) | Howmedica Osteonics Corp. | 1999-07-20 |
| BUECHEL-PAPPAS MODULAR SALVAGE STEM (K982418) | Endotec, Inc. | 1999-04-29 |
| BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 (K960363) | Biomet, Inc. | 1997-02-18 |
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Every clearance here is in the API, with alerts when new ones post.