QKW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3695
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.
- Adverse events (MAUDE)
- 2025: 23 · 2026: 23
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 |
|---|---|---|
| Tornier Pyrocarbon Humeral Head (DEN220012) | Tornier S.A.S. | 2022-12-16 |
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Every clearance here is in the API, with alerts when new ones post.