Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
23510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2026 | K261961 | Ntegrate Threaded Nail System Nvision Biomedical Technologies | HWC |
| Oct 2, 2026 | K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts OsteoCentric Technologies | HWC |
| Sep 25, 2026 | K262975 | Arthrex Beaming System Arthrex, Inc. | HWC |
| Sep 23, 2026 | K260995 | DynaNail Helix® Fixation System MedShape, Inc. | HWC |
| Sep 21, 2026 | K254280 | F.A.S.T Screw Steps Ortho, FR | HWC |
| Sep 4, 2026 | K261057 | ActivaScrew Cannulated COM Bioretec, Ltd., FI | HWC |
| Aug 24, 2026 | K260106 | OsteoCoil GT Active Compression System Flower Orthopedics Corporation DBA Conventus Flower Orthoped | HWC |
| Aug 12, 2026 | K262344 | Large Compression Screws TriMed, Inc. | HWC |
| Aug 5, 2026 | K253858 | GFS - Sterile Screws and Top Hat T.A.G. Medical Products Corporation, Ltd., IL | HWC |
| Jul 22, 2026 | K262075 | Lapidus Screw Kit Relja Innovations, LLC | HWC |
| Jun 25, 2026 | K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw System Arthrex, Inc. | HWC |
| Jun 5, 2026 | K253108 | VEOFIX Snap Off Screw Steps Ortho, FR | HWC |
| May 30, 2026 | K261154 | CoLink® & CoLag® Non-Sterile Screws In2Bones USA, LLC | HWC |
| May 14, 2026 | K261241 | TriMed Compression Screws TriMed, Inc. | HWC |
| May 8, 2026 | K254215 | Arthrex Beaming System Arthrex, Inc. | HWC |
| May 1, 2026 | K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail OSSIO , Ltd., IL | HWC |
| Apr 17, 2026 | K260934 | TITAN Nail; APTUS K-Wire System Medartis AG, CH | HWC |
| Apr 10, 2026 | K252699 | CoAptix S System University of Utah, Department of Orthopaedics | HWC |
| Apr 3, 2026 | K253042 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Mar 18, 2026 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro MedShape, Inc. | HWC |
| Mar 6, 2026 | K260361 | Treace Medical Concepts (TMC) Screw Fixation System Treace Medical Concepts, Inc. | HWC |
| Dec 31, 2025 | K252901 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Nov 6, 2025 | K251555 | Ultra Compression Screw System Pace Surgical | HWC |
| Oct 10, 2025 | K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) Dev4 | HWC |
| Oct 8, 2025 | K250536 | MetaFore Small Screw System Extremity Medical, LLC | HWC |
| Oct 2, 2025 | K252758 | Cannulated Screw and Kirschner (K wire) System Orthonovis, Inc. | HWC |
| Aug 29, 2025 | K252019 | CurvaFix Low Profile System Curvafix, Inc. | HWC |
| Aug 27, 2025 | K251382 | Phoenix Sinus Tarsi Stent System Astra Orthomed, Inc. | HWC |
| Aug 15, 2025 | K250867 | Dunamis Screw and Suture Locking System Dunamis Medical, LLC | HWC |
| Jun 13, 2025 | K250251 | Eleganz Fusion Screw System (Fusion Screw System) Dev4 | HWC |
| Apr 10, 2025 | K243943 | TriMed® Compression Screws TriMed, Inc. | HWC |
| Apr 2, 2025 | K250613 | SnapHammer Hammertoe Correction System Nvision Biomedical Technologies, Inc. | HWC |
| Mar 5, 2025 | K250304 | TITANEX Screw Systems Vilex, LLC | HWC |
| Feb 5, 2025 | K242896 | Caliber Intramedullary Fixation System Nvision Biomedical Technologies | HWC |
| Jan 31, 2025 | K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw Innovate Orthopaedics, Ltd., GB | HWC |
| Jan 10, 2025 | K243195 | Arthrex SS VAL and VAL KreuLock Compression Screw System Arthrex, Inc. | HWC |
| Dec 4, 2024 | K242348 | Locking Screw,CoCrMo Double Medical Technology, Inc., CN | HWC |
| Nov 22, 2024 | K233567 | OsteoCoil Nitinol Compression System (Multiple Component PNs) Flower Orthopedics Corporation Dba Conventus Flower Ortho | HWC |
| Oct 29, 2024 | K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) Tigon Medical | HWC |
| Oct 9, 2024 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts OsteoCentric Technologies | HWC |
| Oct 4, 2024 | K242671 | Treace Medical Concepts (TMC) Screw Fixation System Treace Medical Concepts, Inc. | HWC |
| Aug 31, 2024 | K241592 | Arthrex VAL and VAL KreuLock Compression Screw System Arthrex, Inc. | HWC |
| Aug 2, 2024 | K241359 | Medline UNITE® MIS Foot Recon Screw System Medline Industries, LP | HWC |
| Jul 3, 2024 | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail OSSIO , Ltd., IL | HWC |
| Jun 13, 2024 | K240815 | Arthrex Cannulated Screw System Arthrex, Inc. | HWC |
| Jun 5, 2024 | K233008 | Cannulated Headless Bone Screws Aap Implantate AG, DE | HWC |
| Mar 21, 2024 | K240530 | DynaNail Mini Tapered Hybrid MedShape, Inc. | HWC |
| Mar 11, 2024 | K233912 | ARIX Cannulated Screw System Jeil Medical Corporation, KR | HWC |
| Mar 8, 2024 | K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails OSSIO , Ltd., IL | HWC |
| Feb 16, 2024 | K231453 | SnapHammer Hammertoe Correction System Nvision Biomedical Technologies, Inc. | HWC |
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