HWR
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Driver, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 898 · 2022: 979 · 2023: 1,280 · 2024: 1,211 · 2025: 1,226 · 2026: 714
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 |
|---|---|---|
| KNEE PROSTHESIS DRIVER (K915776) | Kim-Med, Inc. | 1992-06-11 |
| ACROMED ADS BONE NAIL DRIVER (K875054) | Buckman Co., Inc. | 1988-01-28 |
| SCHULTZ PHALANGEAL COMPONENT DRIVER (K870847) | Warsaw Orthopedic, Inc. | 1987-03-13 |
| SCHULTZ METACARPAL COMPONENT DRIVER (K870848) | Warsaw Orthopedic, Inc. | 1987-03-13 |
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Every clearance here is in the API, with alerts when new ones post.