HWT
10 FDA 510(k) clearances · Product code
28 daysmedian time to decision
399 days90th percentile
10clearances measured
FDA profile
- Official device name
- Template
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4800
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 2,177 · 2022: 2,094 · 2023: 2,598 · 2024: 2,416 · 2025: 2,252 · 2026: 1,524
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 |
|---|---|---|
| ORTHOPLAN (K974406) | Ortho-Graphics, Inc. | 1998-02-18 |
| ORTHODOC PREOPERATIVE PLANNER MODEL 500 (K960685) | Integrated Surgical Systems, Inc. | 1997-01-17 |
| KRONNER SPHERICAL CUTTERS (K894228) | Kronner Medical | 1990-07-23 |
| SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (K870843) | Warsaw Orthopedic, Inc. | 1987-05-27 |
| ARTHROSCOPIC MENISCAL SUTURE SYSTEM (K871323) | Orthopedic Systems, Inc. | 1987-05-01 |
| 3M OSTEOTOMY GUIDE (K830360) | 3M Company | 1983-03-01 |
| MOLDED POLYSULFONE TRIAL PROSTHESIS (K811205) | Shannon Group | 1981-05-21 |
| KNEE INSTRUMENTATION, CONDYLAR (K781091) | Biomet, Inc. | 1978-07-17 |
| WORRELL TRIAL PATELLA (K771709) | Depuy, Inc. | 1977-10-06 |
| WORRELL PATELLA TEMPLATE (K771710) | Depuy, Inc. | 1977-10-06 |
Track HWT automatically
Every clearance here is in the API, with alerts when new ones post.