HWC — Screw, Fixation, Bone Class II
FDA product code HWC covers "Screw, Fixation, Bone", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260809 | arthrex | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | June 25, 2026 |
| K253108 | steps ortho | VEOFIX Snap Off Screw | June 5, 2026 |
| K261154 | in2bones usa | CoLink® & CoLag® Non-Sterile Screws | May 30, 2026 |
| K261241 | trimed | TriMed Compression Screws | May 14, 2026 |
| K254215 | arthrex | Arthrex Beaming System | May 8, 2026 |
| K254077 | ossio | OSSIOfiber® Threaded Trimmable Fixation Nail | May 1, 2026 |
| 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 |