LRN
8 FDA 510(k) clearances · Product code
103 daysmedian time to decision
196 days90th percentile
8clearances measured
FDA profile
- Official device name
- Wire, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2021: 118 · 2022: 106 · 2023: 140 · 2024: 87 · 2025: 83 · 2026: 31
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 |
|---|---|---|
| NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (K002755) | T. Korossurgical Instruments Corp. | 2000-12-04 |
| STAINLESS STEEL SOFT SUTURE WIRE (K990355) | Bregma International Trading Company , Ltd. | 1999-07-08 |
| J-FX CERCLAGE SYSTEM (K971682) | Johnson & Johnson Professionals, Inc. | 1997-06-27 |
| OXBORO-MEDICAL PIN COVERS (K952783) | Oxboro Medical Intl., Inc. | 1995-09-15 |
| ORTHOPAEDIC WIRES (K942603) | Acu Med, Inc. | 1994-11-09 |
| TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (K900926) | Howmedica Corp. | 1990-04-23 |
| SONGER WIRING SYSTEM (K892651) | Danek Medical, Inc. | 1989-07-25 |
| TYPE 316L COTTER WIRE (K864375) | Winn Hirsch & Assoc. | 1987-05-20 |
Track LRN automatically
Every clearance here is in the API, with alerts when new ones post.