PAO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA definition
- Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
- Adverse events (MAUDE)
- 2018: 94 · 2019: 17 · 2023: 64 · 2024: 85 · 2025: 88 · 2026: 60
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 |
|---|---|---|
| PERFORM Humeral System – Stem (K201315) | Tornier, Inc. | 2020-09-11 |
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Every clearance here is in the API, with alerts when new ones post.