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 |
|---|---|---|---|
| Jan 18, 2024 | K234040 | TriMed Threaded Intramedullary Nail System TriMed, Inc. | HWC |
| Jan 18, 2024 | K231860 | TDM Screw System Tdm Co., Ltd., KR | HWC |
| Jan 4, 2024 | K230507 | Zimed Distal Medial Tibial Plate and Screw System Zimed Medikal, TR | HWC |
| Dec 21, 2023 | K233396 | Cannulated Screw System Smith & Nephew, Inc. | HWC |
| Nov 3, 2023 | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension Medartis AG, CH | HWC |
| Oct 12, 2023 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices Paragon 28, Inc. | HWC |
| Sep 29, 2023 | K231649 | Intraosseous Fusion Device System Auxano Medical, LLC | HWC |
| Sep 15, 2023 | K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code AC Trax Surgical | HWC |
| Sep 11, 2023 | K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System Vilex, LLC | HWC |
| Sep 5, 2023 | K231819 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw Innovate Orthopaedics Limited, GB | HWC |
| Aug 30, 2023 | K223468 | Nexis® compressive screws Novastep, FR | HWC |
| Jul 27, 2023 | K231236 | IBS-B MIS Beveled Screw System In2bones USA, LLC | HWC |
| Jul 18, 2023 | K230945 | Forma Medical Headless Compression Screw Forma Medical, Inc. | HWC |
| Jun 29, 2023 | K230595 | OsteoCentric ACL Fixation System OsteoCentric Technologies | HWC |
| Jun 26, 2023 | K230867 | Bone Bolt System University of Utah, Department of Orthopaedics | HWC |
| Jun 12, 2023 | K230397 | Cut Screw - Percutaneous Compression Screw GM Dos Reis Industria e Comercio Ltda., BR | HWC |
| Jun 9, 2023 | K230744 | Acumed Acutrak 3 Headless Compression Screw System Acumed, LLC | HWC |
| Apr 28, 2023 | K230908 | Hand Trauma Threaded Nail System Skeletal Dynamics, Inc. | HWC |
| Apr 19, 2023 | K230053 | SimpliFix Hip System Stabiliz Orthopaedics, Inc. | HWC |
| Apr 17, 2023 | K230749 | TriMed Threaded Intramedullary Nail System TriMed, Inc. | HWC |
| Feb 28, 2023 | K223392 | REVCON (TM) Screw System Voom Medical Devices, Inc. | HWC |
| Feb 17, 2023 | K221645 | PROstep(TM) MIS 5mm Chamfer Screw System Wright Medical Technology | HWC |
| Feb 16, 2023 | K230118 | Bony Trauma Extremity System (BTES) Screw Range, NX Nail Field Orthopaedics Pty, Ltd., AU | HWC |
| Feb 13, 2023 | K223761 | OIC Intramedullary Screw System Orthopaedic Implant Company | HWC |
| Jan 25, 2023 | K223847 | CREED Cannulated Screws Glw, Inc. | HWC |
| Jan 10, 2023 | K222799 | Haymaker® Screw System Orthocircle Spine D.B.A. OC Medical Devices | HWC |
| Jan 10, 2023 | K221090 | Metal Cannulated Screw Double Medical Technology, Inc., CN | HWC |
| Dec 29, 2022 | K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional Acumed, LLC | HWC |
| Dec 23, 2022 | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm OSSIO , Ltd., IL | HWC |
| Dec 16, 2022 | K223184 | Phantom Metatarsal Shortening System Paragon 28, Inc. | HWC |
| Dec 16, 2022 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant Brm Extremities, IT | HWC |
| Dec 13, 2022 | K221342 | REDEMPTION Beaming System Vilex, LLC | HWC |
| Dec 12, 2022 | K220921 | Metal Bone Screw Double Medical Technology, Inc., CN | HWC |
| Nov 23, 2022 | K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws Avanti Orthopaedics, Inc. | HWC |
| Nov 15, 2022 | K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System Treace Medical Concepts, Inc. | HWC |
| Nov 4, 2022 | K221610 | Nextra CH Cannulated Hammertoe System Nextremity Solutions, Inc. | HWC |
| Oct 27, 2022 | K222505 | CurvaFix IM System Curvafix, Inc. | HWC |
| Sep 20, 2022 | K220359 | Tandry Compression Screw System Microware Precision Co., Ltd., TW | HWC |
| Sep 19, 2022 | K220839 | Arthrex Compression FT Pins Arthrex, Inc. | HWC |
| Sep 8, 2022 | K222409 | CAPTIVATE® Compression Screws Globus Medical, Inc. | HWC |
| Aug 3, 2022 | K213614 | Cannulated Screws Maxxion Medical, LLC | HWC |
| Jun 10, 2022 | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System Stryker GmbH | HWC |
| May 12, 2022 | K220723 | Hand Trauma Screw System Skeletal Dynamics, Inc. | HWC |
| Apr 27, 2022 | K220892 | ExsoMed INnate NanoTM Lag Screw System Exsomed Corp. | HWC |
| Apr 13, 2022 | K210146 | Cannulated Compression Device System Orthopedic Designs North America, Inc. | HWC |
| Mar 22, 2022 | K220511 | Medline UNITE IM Fibula Implant Medline Industries, LP | HWC |
| Mar 10, 2022 | K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System Signus Medizintechnik GmbH, DE | HWC |
| Feb 3, 2022 | K203335 | MectaScrew Extension Medacta International S.A., CH | HWC |
| Jan 31, 2022 | K211628 | MIS Precision Chevron Bunion System Relja Innovations, LLC | HWC |
| Jan 18, 2022 | K213572 | JuniOrtho Plating System Orthofix Srl, IT | HWC |
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