HTW
11 FDA 510(k) clearances · Product code
41 daysmedian time to decision
193 days90th percentile
11clearances measured
FDA profile
- Official device name
- Bit, Drill
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 1,569 · 2022: 1,519 · 2023: 1,772 · 2024: 1,422 · 2025: 1,527 · 2026: 986
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 |
|---|---|---|
| Renovo Life Hard Carbon Coated Drill Bit (K151661) | Renovo Life, LLC | 2016-01-15 |
| AGEE-WRISTJACK PRE-DRILL KIT (K942906) | Hand Biomechanics Lab, Inc. | 1994-12-22 |
| REAMER BIT (K930339) | Neoligaments, Ltd. | 1993-08-06 |
| CANNULATED DRILL BIT (K915692) | W. L. Gore & Associates, Inc. | 1992-01-16 |
| MITEK ANCHOR DRILL (K892903) | Mitek Surgical Products, Inc. | 1989-10-06 |
| FEMORAL CEMENT REMOVAL INSTRUMENTS (K870217) | Kenneth J. Hoek, M.D., Inc. | 1987-02-06 |
| GLENOID DRILL (K863147) | Bowen & Company, Inc. | 1986-09-05 |
| DRILL BIT (K841629) | Plastafil, Inc. | 1984-08-27 |
| BONE PLUGGING TOOL (K834229) | Standard Surgical | 1984-01-10 |
| SURGICAL DRILL BITS (K831712) | Medical Specialists IN Packaging | 1983-07-07 |
| UNIVERSALL DRILL GUIDE (K820226) | Ortho Pared Instruments, Inc. | 1982-02-04 |
Track HTW automatically
Every clearance here is in the API, with alerts when new ones post.