ISY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Joint, Knee, External Limb Component
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2020: 80 · 2021: 35 · 2022: 23 · 2023: 24 · 2025: 28 · 2026: 20
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 |
|---|---|---|
| REL-K ARTIFICAL LIMB PROSTHESIS (K101859) | Rizzoli Ortopedica S.P.A. | 2010-10-13 |
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Every clearance here is in the API, with alerts when new ones post.