Product code HWC
- Device name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | 2026-09-04 |
| K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026-08-24 |
| K262344 | Large Compression Screws | TriMed, Inc. | 2026-08-12 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026-06-25 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | 2026-03-18 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 |
| K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025-11-06 |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025-10-10 |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025-10-08 |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025-08-29 |
| K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | 2025-08-27 |
| K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025-08-15 |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | 2025-06-13 |
| K243943 | TriMed® Compression Screws | TriMed, Inc. | 2025-04-10 |
| K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025-04-02 |
| K250304 | TITANEX Screw Systems | Vilex, LLC | 2025-03-05 |
| K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | 2025-02-05 |
| K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. | 2025-01-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556822265 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556823026 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556823002 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822999 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822982 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822975 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822968 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822951 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822524 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822463 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822432 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822388 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822340 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822333 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822319 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556821992 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822241 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822203 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822180 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822159 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822111 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822104 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822098 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822081 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822067 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822043 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822036 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822029 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822012 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556822005 | Capture High Torque Screw System | Smith & Nephew, Inc. | 2022-12-21 |