HWC — Screw, Fixation, Bone Class II
FDA Device Classification
Classification Details
- Product Code
- HWC
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K260934 | medartis | TITAN Nail; APTUS K-Wire System | April 17, 2026 |
| K252699 | university of utah, department of orthopaedics | CoAptix S System | April 10, 2026 |
| K253042 | tyber medical | Tyber Medical Trauma Screw | April 3, 2026 |
| K254110 | medshape | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaCl | March 18, 2026 |
| K260361 | treace medical concepts | Treace Medical Concepts (TMC) Screw Fixation System | March 6, 2026 |
| K252901 | tyber medical | Tyber Medical Trauma Screw | December 31, 2025 |
| K251555 | pace surgical | Ultra Compression Screw System | November 6, 2025 |
| K252312 | dev4 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | October 10, 2025 |
| K250536 | extremity medical | MetaFore Small Screw System | October 8, 2025 |
| K252758 | orthonovis | Cannulated Screw and Kirschner (K wire) System | October 2, 2025 |
| K252019 | curvafix | CurvaFix Low Profile System | August 29, 2025 |
| K251382 | astra orthomed | Phoenix Sinus Tarsi Stent System | August 27, 2025 |
| K250867 | dunamis medical | Dunamis Screw and Suture Locking System | August 15, 2025 |
| K250251 | dev4 | Eleganz Fusion Screw System (Fusion Screw System) | June 13, 2025 |
| K243943 | trimed | TriMed® Compression Screws | April 10, 2025 |
| K250613 | nvision biomedical technologies | SnapHammer Hammertoe Correction System | April 2, 2025 |
| K250304 | vilex | TITANEX Screw Systems | March 5, 2025 |
| K242896 | nvision biomedical technologies | Caliber Intramedullary Fixation System | February 5, 2025 |
| K242442 | innovate orthopaedics | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | January 31, 2025 |
| K243195 | arthrex | Arthrex SS VAL and VAL KreuLock Compression Screw System | January 10, 2025 |