QHQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Total Shoulder Arthroplasty System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- To treat pain and lack of function in the shoulder.
- Adverse events (MAUDE)
- 2020: 21 · 2021: 23 · 2023: 17 · 2024: 32 · 2025: 27
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 |
|---|---|---|
| Arthrex Eclipse Shoulder Prosthesis System (K183194) | Arthrex, Inc. | 2019-07-26 |
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