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 |
|---|---|---|---|
| K261057 | Bioretec | ActivaScrew Cannulated COM | Sep 4, 2026 |
| K260106 | Flower Orthopedics Corporation Dba Conventus Flower Orthoped | OsteoCoil GT Active Compression System | Aug 24, 2026 |
| K262344 | Trimed | Large Compression Screws | Aug 12, 2026 |
| K253858 | T.A.G. Medical Products Corporation | GFS - Sterile Screws and Top Hat | Aug 5, 2026 |
| K262075 | Relja Innovations | Lapidus Screw Kit | Jul 22, 2026 |
| K260809 | Arthrex | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Jun 25, 2026 |
| K253108 | Steps Ortho | VEOFIX Snap Off Screw | Jun 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 | Apr 17, 2026 |
| K252699 | University Of Utah, Department Of Orthopaedics | CoAptix S System | Apr 10, 2026 |
| K253042 | Tyber Medical | Tyber Medical Trauma Screw | Apr 3, 2026 |
| K254110 | Medshape | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaCl | Mar 18, 2026 |
| K260361 | Treace Medical Concepts | Treace Medical Concepts (TMC) Screw Fixation System | Mar 6, 2026 |
| K252901 | Tyber Medical | Tyber Medical Trauma Screw | Dec 31, 2025 |
| K251555 | Pace Surgical | Ultra Compression Screw System | Nov 6, 2025 |
| K252312 | Dev4 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Oct 10, 2025 |
| K250536 | Extremity Medical | MetaFore Small Screw System | Oct 8, 2025 |