Screw, Fixation, Bone
FDA product code HWC · Class II (moderate risk) · 21 CFR 888.3040 · Orthopedic
1,065510(k) clearances
0PMA approvals
360recalls
Implantimplanted device
Manufacturers
- Arthrex, Inc. 46
- Synthes (Usa) 31
- Wrightmedicaltechnologyinc 31
- Smith & Nephew, Inc. 27
- Biomet, Inc. 24
- Linvatec Corp. 17
- Extremity Medical, LLC 16
- Osteomed LP 15
- Depuy, Inc. 14
- Depuy Mitek, A Johnson & Johnson Company 13
- Zimmer, Inc. 12
- Howmedica Corp. 12
- Inion , Ltd. 12
- Nextremity Solutions, Inc. 11
- Biocomposites, Ltd. 11
- Onyx Medical Corp. 11
- New Deal, S.A. 10
- Bionx Implants, Inc. 10
- Coapt Systems, Inc. 10
- Acu Med, Inc. 9
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | OSSIO , Ltd. | 05/01/2026SE |
| K260934 | TITAN Nail; APTUS K-Wire SystemHWC · Special | Medartis AG | 04/17/2026SE |
| K252699 | CoAptix S SystemHWC · Traditional | University of Utah, Department of Orthopaedics | 04/10/2026SE |
| K253042 | Tyber Medical Trauma ScrewHWC · Traditional | Tyber Medical, LLC | 04/03/2026SE |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…HWC · Traditional | MedShape, Inc. | 03/18/2026SE |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation SystemHWC · Special | Treace Medical Concepts, Inc. | 03/06/2026SE |
| K252901 | Tyber Medical Trauma ScrewHWC · Traditional | Tyber Medical, LLC | 12/31/2025SE |
| K251555 | Ultra Compression Screw SystemHWC · Traditional | Pace Surgical | 11/06/2025SE |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System)HWC · Traditional | Dev4 | 10/10/2025SE |
| K250536 | MetaFore Small Screw SystemHWC · Traditional | Extremity Medical, LLC | 10/08/2025SE |
| K252758 | Cannulated Screw and Kirschner (K wire) SystemHWC · Special | Orthonovis, Inc. | 10/02/2025SE |
| K252019 | CurvaFix Low Profile SystemHWC · Traditional | Curvafix, Inc. | 08/29/2025SE |
| K251382 | Phoenix Sinus Tarsi Stent SystemHWC · Traditional | Astra Orthomed, Inc. | 08/27/2025SE |
| K250867 | Dunamis Screw and Suture Locking SystemHWC · Traditional | Dunamis Medical, LLC | 08/15/2025SE |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System)HWC · Traditional | Dev4 | 06/13/2025SE |
| K243943 | TriMed® Compression ScrewsHWC · Traditional | TriMed, Inc. | 04/10/2025SE |
| K250613 | SnapHammer Hammertoe Correction SystemHWC · Special | Nvision Biomedical Technologies, Inc. | 04/02/2025SE |
| K250304 | TITANEX Screw SystemsHWC · Special | Vilex, LLC | 03/05/2025SE |
| K242896 | Caliber Intramedullary Fixation SystemHWC · Traditional | Nvision Biomedical Technologies | 02/05/2025SE |
| K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewHWC · Traditional | Innovate Orthopaedics, Ltd. | 01/31/2025SE |
| K243195 | Arthrex SS VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 01/10/2025SE |
| K242348 | Locking Screw,CoCrMoHWC · Abbreviated | Double Medical Technology, Inc. | 12/04/2024SE |
| K233567 | OsteoCoil Nitinol Compression System (Multiple Component PNs)HWC · Traditional | Flower Orthopedics Corporation Dba Conventus… | 11/22/2024SE |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE)HWC · Traditional | Tigon Medical | 10/29/2024SE |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and NutsHWC · Special | OsteoCentric Technologies | 10/09/2024SE |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation SystemHWC · Special | Treace Medical Concepts, Inc. | 10/04/2024SE |
| K241592 | Arthrex VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 08/31/2024SE |
| K241359 | Medline UNITE® MIS Foot Recon Screw SystemHWC · Traditional | Medline Industries, LP | 08/02/2024SE |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | OSSIO , Ltd. | 07/03/2024SE |
| K240815 | Arthrex Cannulated Screw SystemHWC · Traditional | Arthrex, Inc. | 06/13/2024SE |
| K233008 | Cannulated Headless Bone ScrewsHWC · Traditional | Aap Implantate AG | 06/05/2024SE |
| K240530 | DynaNail Mini Tapered HybridHWC · Special | MedShape, Inc. | 03/21/2024SE |
| K233912 | ARIX Cannulated Screw SystemHWC · Traditional | Jeil Medical Corporation | 03/11/2024SE |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation NailsHWC · Traditional | OSSIO , Ltd. | 03/08/2024SE |
| K231453 | SnapHammer Hammertoe Correction SystemHWC · Traditional | Nvision Biomedical Technologies, Inc. | 02/16/2024SE |
| K234040 | TriMed Threaded Intramedullary Nail SystemHWC · Special | TriMed, Inc. | 01/18/2024SE |
| K231860 | TDM Screw SystemHWC · Special | Tdm Co., Ltd. | 01/18/2024SE |
| K230507 | Zimed Distal Medial Tibial Plate and Screw SystemHWC · Traditional | Zimed Medikal | 01/04/2024SE |
| K233396 | Cannulated Screw SystemHWC · Traditional | Smith & Nephew, Inc. | 12/21/2023SE |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWC · Traditional | Medartis AG | 11/03/2023SE |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…HWC · Traditional | Paragon 28, Inc. | 10/12/2023SE |
| K231649 | Intraosseous Fusion Device SystemHWC · Traditional | Auxano Medical, LLC | 09/29/2023SE |
| K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…HWC · Traditional | Trax Surgical | 09/15/2023SE |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw SystemHWC · Traditional | Vilex, LLC | 09/11/2023SE |
| K231819 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewHWC · Traditional | Innovate Orthopaedics Limited | 09/05/2023SE |
| K223468 | Nexis® compressive screwsHWC · Abbreviated | Novastep | 08/30/2023SE |
| K231236 | IBS-B MIS Beveled Screw SystemHWC · Traditional | In2bones USA, LLC | 07/27/2023SE |
| K230945 | Forma Medical Headless Compression ScrewHWC · Traditional | Forma Medical, Inc. | 07/18/2023SE |
| K230595 | OsteoCentric ACL Fixation SystemHWC · Traditional | OsteoCentric Technologies | 06/29/2023SE |
| K230867 | Bone Bolt SystemHWC · Traditional | University of Utah, Department of Orthopaedics | 06/26/2023SE |
| K230397 | Cut Screw - Percutaneous Compression ScrewHWC · Traditional | GM Dos Reis Industria e Comercio Ltda. | 06/12/2023SE |
| K230744 | Acumed Acutrak 3 Headless Compression Screw SystemHWC · Traditional | Acumed, LLC | 06/09/2023SE |
| K230908 | Hand Trauma Threaded Nail SystemHWC · Special | Skeletal Dynamics, Inc. | 04/28/2023SE |
| K230053 | SimpliFix Hip SystemHWC · Traditional | Stabiliz Orthopaedics, Inc. | 04/19/2023SE |
| K230749 | TriMed Threaded Intramedullary Nail SystemHWC · Special | TriMed, Inc. | 04/17/2023SE |
| K223392 | REVCON (TM) Screw SystemHWC · Traditional | Voom Medical Devices, Inc. | 02/28/2023SE |
| K221645 | PROstep(TM) MIS 5mm Chamfer Screw SystemHWC · Abbreviated | Wright Medical Technology | 02/17/2023SE |
| K230118 | Bony Trauma Extremity System (BTES) Screw Range, NX NailHWC · Special | Field Orthopaedics Pty, Ltd. | 02/16/2023SE |
| K223761 | OIC Intramedullary Screw SystemHWC · Traditional | Orthopaedic Implant Company | 02/13/2023SE |
| K223847 | CREED Cannulated ScrewsHWC · Special | Glw, Inc. | 01/25/2023SE |
| K222799 | Haymaker® Screw SystemHWC · Traditional | Orthocircle Spine D.B.A. OC Medical Devices | 01/10/2023SE |
| K221090 | Metal Cannulated ScrewHWC · Traditional | Double Medical Technology, Inc. | 01/10/2023SE |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalHWC · Traditional | Acumed, LLC | 12/29/2022SE |
| K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmHWC · Traditional | OSSIO , Ltd. | 12/23/2022SE |
| K223184 | Phantom Metatarsal Shortening SystemHWC · Traditional | Paragon 28, Inc. | 12/16/2022SE |
| K222820 | BRM TOOL Screws, BIOPLAN Subtalar ImplantHWC · Traditional | Brm Extremities | 12/16/2022SE |
| K221342 | REDEMPTION Beaming SystemHWC · Traditional | Vilex, LLC | 12/13/2022SE |
| K220921 | Metal Bone ScrewHWC · Traditional | Double Medical Technology, Inc. | 12/12/2022SE |
| K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…HWC · Traditional | Avanti Orthopaedics, Inc. | 11/23/2022SE |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation SystemHWC · Traditional | Treace Medical Concepts, Inc. | 11/15/2022SE |
| K221610 | Nextra CH Cannulated Hammertoe SystemHWC · Traditional | Nextremity Solutions, Inc. | 11/04/2022SE |
| K222505 | CurvaFix IM SystemHWC · Traditional | Curvafix, Inc. | 10/27/2022SE |
| K220359 | Tandry Compression Screw SystemHWC · Traditional | Microware Precision Co., Ltd. | 09/20/2022SE |
| K220839 | Arthrex Compression FT PinsHWC · Traditional | Arthrex, Inc. | 09/19/2022SE |
| K222409 | CAPTIVATE® Compression ScrewsHWC · Special | Globus Medical, Inc. | 09/08/2022SE |
| K213614 | Cannulated ScrewsHWC · Traditional | Maxxion Medical, LLC | 08/03/2022SE |
| K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemHWC · Traditional | Stryker GmbH | 06/10/2022SE |
| K220723 | Hand Trauma Screw SystemHWC · Traditional | Skeletal Dynamics, Inc. | 05/12/2022SE |
| K220892 | ExsoMed INnate NanoTM Lag Screw SystemHWC · Special | Exsomed Corp. | 04/27/2022SE |
| K210146 | Cannulated Compression Device SystemHWC · Traditional | Orthopedic Designs North America, Inc. | 04/13/2022SE |
| K220511 | Medline UNITE IM Fibula ImplantHWC · Special | Medline Industries, LP | 03/22/2022SE |
| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization SystemHWC · Traditional | Signus Medizintechnik GmbH | 03/10/2022SE |
| K203335 | MectaScrew ExtensionHWC · Traditional | Medacta International S.A. | 02/03/2022SE |
| K211628 | MIS Precision Chevron Bunion SystemHWC · Traditional | Relja Innovations, LLC | 01/31/2022SE |
| K213572 | JuniOrtho Plating SystemHWC · Traditional | Orthofix Srl | 01/18/2022SE |
| K203773 | BRM TOOL ScrewsHWC · Traditional | Brm Extremities Srl | 01/14/2022SE |
| K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemHWC · Traditional | Stryker GmbH | 01/11/2022SE |
| K203595 | DynaFuse Fixation SystemHWC · Traditional | MedShape, Inc. | 01/04/2022SE |
| K212547 | Quick-Start ScrewsHWC · Traditional | Innovate Orthopaedics Limited | 12/30/2021SE |
| K211770 | R3ACT Stabilization SystemHWC · Traditional | Paragon 28, Inc. | 12/25/2021SE |
| K213596 | OSSIOfiber Compression Screw, 3.5mmHWC · Traditional | OSSIO , Ltd. | 12/21/2021SE |
| K213301 | InCore Subtalar SystemHWC · Traditional | Nextremity Solutions, Inc. | 12/21/2021SE |
| K213530 | Nextra CH Cannulated Hammertoe SystemHWC · Special | Nextremity Solutions, Inc. | 12/09/2021SE |
| K213421 | Vector® Hammertoe Correction SystemHWC · Special | Nvision Biomedical Technologies, Inc. | 11/19/2021SE |
| K212996 | Sterile PHALINX Hammertoe SystemHWC · Traditional | Wrightmedicaltechnologyinc | 11/16/2021SE |
| K202326 | BESPA Charcot SystemHWC · Traditional | Bespa Global, LLC | 11/09/2021SE |
| K213036 | Treace Medical Concepts (TMC) Screw Fixation SystemHWC · Special | Treace Medical Concepts, Inc. | 10/21/2021SE |
| K210490 | ChM 4.5mm Cortical screwsHWC · Traditional | Chm Sp. Z O.O. | 10/05/2021SE |
| K211996 | Nexta PEEK Hammertoe Correction SystemHWC · Traditional | Nextremity Solutions, Inc. | 09/23/2021SE |
| K210792 | Auxein Nailing SystemHWC · Special | Auxein Medical Private Limited | 08/25/2021SE |
| K203029 | Auxilock Titanium Interference ScrewHWC · Traditional | Auxein Medical Private Limited | 08/20/2021SE |
| K211783 | TriMed Threaded Intramedullary Nail SystemHWC · Traditional | TriMed, Inc. | 08/06/2021SE |
| K211435 | PAO Cortical ScrewHWC · Traditional | Medacta International S.A. | 08/06/2021SE |
| K211290 | Cannulated Fasteners and NutsHWC · Special | OsteoCentric Technologies | 08/03/2021SE |
| K210159 | IntraLock SystemHWC · Traditional | Fusion Orthopedics, LLC | 07/23/2021SE |
| K211944 | Medline UNITE® Digital Fusion Screw SystemHWC · Special | Medline Industries, Inc. | 07/22/2021SE |
| K210994 | Arthrex Beveled FT ScrewsHWC · Traditional | Arthrex, Inc. | 06/01/2021SE |
| K211261 | Axis Charcot Fixation SystemHWC · Special | Extremity Medical, LLC | 05/28/2021SE |
| K203228 | DART-FIRE EDGE Cannulated Screw SystemHWC · Traditional | Wright Medical | 05/11/2021SE |
| K210754 | Cannulated Fasteners and NutsHWC · Special | OsteoCentric Technologies | 04/14/2021SE |
| K210268 | LTJ Screws and WasherHWC · Special | Azurmeds, Inc. | 02/26/2021SE |
| K203381 | Dynanail Mini HybridHWC · Traditional | MedShape, Inc. | 01/15/2021SE |
| K203105 | Inion CompressOn ScrewHWC · Traditional | Inion OY | 01/13/2021SE |
| K193497 | Fixone Biocomposite Interference ScrewHWC · Traditional | Aju Pharm Co., Ltd. | 01/05/2021SE |
| K203239 | Arthrex Low Profile ScrewsHWC · Traditional | Arthrex, Inc. | 12/30/2020SE |
| K203467 | WishBone Medical Plate and Screw SystemHWC · Special | Wishbone Medical, Inc. | 12/23/2020SE |
| K200291 | CREED Cannulated ScrewsHWC · Traditional | Glw Medical, Inc. | 12/16/2020SE |
| K203011 | Monster Screw SystemHWC · Special | Paragon 28, Inc. | 11/13/2020SE |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…HWC · Traditional | Medartis AG | 11/06/2020SE |
| K202817 | GEO Bone Screw SystemHWC · Special | Gramercy Extremity Orthopedics, LLC | 10/22/2020SE |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC · Special | Osteomed, LLC | 10/15/2020SE |
| K202569 | Responsive Arthroscopy Interference Screw SystemHWC · Special | Responsive Arthroscopy, LLC | 09/23/2020SE |
| K200987 | LTJ Screws and WasherHWC · Traditional | Azurmeds, Inc. | 09/22/2020SE |
| K201850 | Vector Hammertoe Correction SystemHWC · Special | Nvision Biomedical Technologies, Inc. | 08/04/2020SE |
| K193660 | OSSIOfiber Compression ScrewsHWC · Traditional | OSSIO , Ltd. | 07/30/2020SE |
| K201662 | REDUCT® Headless Compression Screw SystemHWC · Special | Skeletal Dynamics, Inc. | 07/16/2020SE |
| K201556 | Intraosseous Fixation SystemHWC · Special | Extremity Medical, LLC | 07/08/2020SE |
| K200840 | DuoHex CH Cannulated Hammertoe SystemHWC · Traditional | Nextremity Solutions, Inc. | 06/26/2020SE |
| K200226 | RetroFixHWC · Traditional | Retrofix Screws, LLC | 06/26/2020SE |
| K201430 | InFrame Cannulated Fixation SystemHWC · Special | Exsomed Corp. | 06/20/2020SE |
| K201319 | Medline UNITE Jones Fracture Screw SystemHWC · Special | Medline Industires, Inc. | 06/17/2020SE |
| K200124 | InCore MPJ SystemHWC · Traditional | Nextremity Solutions, Inc. | 05/13/2020SE |
| K200914 | Healix Compression Screw SystemHWC · Special | Nvision Biomedical Technologies, Inc. | 05/05/2020SE |
| K200259 | Headless Compression Screw SystemHWC · Special | Osteocentric Extremities, LLC | 05/04/2020SE |
| K191995 | S4 Screw SystemHWC · Traditional | Subchondral Solutions, Inc. | 04/18/2020SE |
| K193366 | T2 IcfHWC · Traditional | Stryker GmbH | 03/20/2020SE |
| K193491 | restor3d Metallic Interference ScrewHWC · Traditional | Restor3D | 03/19/2020SE |
| K192096 | Omnia Medical Trauma ScrewsHWC · Traditional | Omnia Medical, LLC | 02/27/2020SE |
| K193451 | Titanium Interference ScrewsHWC · Traditional | Biomet, Inc. | 02/24/2020SE |
| K193156 | Arthrex Mini Comprehensive Fixation System - 1.0mm ScrewsHWC · Traditional | Arthrex, Inc. | 02/10/2020SE |
| K192975 | Tyber Medical Trauma ScrewsHWC · Traditional | Tyber Medical, LLC | 01/09/2020SE |
| K192974 | Tyber Medical Trauma ScrewHWC · Traditional | Tyber Medical, LLC | 01/08/2020SE |
| K192578 | InCore TMT SystemHWC · Traditional | Nextremity Solutions, Inc. | 12/31/2019SE |
| K192745 | DePuy Synthes Trauma ScrewsHWC · Traditional | Synthes (Usa) Products, LLC / Depuy… | 11/26/2019SE |
| K192417 | ARIX Cannulated Screw SystemHWC · Traditional | Jeil Medical Corporation | 11/26/2019SE |
| K191651 | Arthrex Nano SwiveLock Suture AnchorHWC · Traditional | Arthrex, Inc. | 11/06/2019SE |
| K190921 | Arthrex Low Profile ScrewsHWC · Traditional | Arthrex, Inc. | 10/30/2019SE |
| K191771 | SECURE ScrewHWC · Traditional | A.M. Surgical, Inc. | 10/16/2019SE |
| K190830 | TDM Screw SystemsHWC · Traditional | Tdm Co., Ltd. | 09/13/2019SE |
| K191424 | Interphalangeal Joint Fusion Device RangeHWC · Traditional | Neosteo | 08/28/2019SE |
| K191342 | CrossRoads Screw SystemHWC · Special | Crossroads Extemity Systems, LLC | 08/19/2019SE |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) SystemHWC · Traditional | Wrightmedicaltechnologyinc | 08/13/2019SE |
| K191289 | Bone Screw Line AdditionHWC · Traditional | Vilex IN Tennessee, Inc. | 07/29/2019SE |
| K191817 | ActivOrtho Continuous Compression Screw SystemHWC · Traditional | Activortho, Inc. | 07/26/2019SE |
| K190324 | OrthoPediatrics Cannulated Screw SystemHWC · Traditional | OrthoPediatrics Corp. | 07/05/2019SE |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw SystemHWC · Traditional | Treace Medical Concepts, Inc. | 06/13/2019SE |
| K183104 | Mini Cannulated Headed and Headless Screw SetHWC · Traditional | Stryker GmbH | 06/10/2019SE |
| K190231 | InCore® Lapidus Sterile KitsHWC · Traditional | Nextremity Solutions, Inc. | 05/24/2019SE |
| K182342 | IntraLock Lapidus SystemHWC · Traditional | Fusion Orthopedics, LLC | 05/21/2019SE |
| K183395 | Arthrex 2.5 mm Tenodesis ScrewHWC · Traditional | Arthrex, Inc. | 04/17/2019SE |
| K190586 | Monster® Screw SystemHWC · Special | Paragon 28, Inc. | 04/03/2019SE |
| K183628 | Arthrex TensionLoc SystemHWC · Traditional | Arthrex, Inc. | 03/26/2019SE |
| K190430 | OsteoCentric Bone Plate and Screw SystemHWC · Special | Osteocentric Trauma | 03/22/2019SE |
| K183026 | Wright Jones Fracture SystemHWC · Traditional | Wrightmedicaltechnologyinc | 03/13/2019SE |
| K183603 | INnate Cannulated Screw SystemHWC · Special | Exsomed Corporation | 03/12/2019SE |
| K181610 | ActivOrtho Nitinol Compression Screw SystemHWC · Traditional | Activortho, Inc. | 03/12/2019SE |
| K180050 | CurvaFix Intramedullary Rodscrew SystemHWC · Traditional | Curvafix, Inc. | 03/01/2019SE |
| K183055 | Vector Hammertoe Correction SystemHWC · Traditional | Nvision Biomedical Technologies, LLC | 02/19/2019SE |
| K182677 | DynaNail MiniHWC · Traditional | MedShape, Inc. | 02/14/2019SE |
| K190035 | Biomet Headless Compression and Twist-Off ScrewsHWC · Special | Biomet, Inc. | 02/07/2019SE |
| K182955 | EZStart Interference ScrewHWC · Traditional | Conmed Corporation | 01/22/2019SE |
| K181377 | PROSTEP MICA Screw SystemHWC · Special | Wrightmedicaltechnologyinc | 01/11/2019SE |
| K182989 | AURORA Screw SystemHWC · Traditional | MiRus, LLC | 12/18/2018SE |
| K182361 | Arthrex Compression FT ScrewsHWC · Traditional | Arthrex, Inc. | 12/18/2018SE |
| K180670 | ICONN Campbell Interference ScrewHWC · Traditional | Iconn Orthopedics, LLC | 12/07/2018SE |
| K182949 | Healix Compression Screw SystemHWC · Traditional | Nvision Biomedical Technologies, LLC | 12/04/2018SE |
| K182684 | HammerTechTM Fixation SystemHWC · Traditional | Fusion Orthopedics, LLC | 11/23/2018SE |
| K180573 | Responsive Arthroscopy Interference Screw SystemHWC · Traditional | Responsive Arthroscopy, LLC | 11/23/2018SE |
| K180541 | DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC · Traditional | Synthes USA Products, LLC | 11/21/2018SE |
| K181898 | Two-Step Implant SystemHWC · Traditional | Trilliant Surgical | 10/26/2018SE |
| K182148 | SILVERBACK Gorilla Plating SystemHWC · Special | Paragon 28, Inc. | 09/07/2018SE |
| K180348 | Field Orthopaedics Micro Screw SystemHWC · Traditional | Field Orthopaedics Pty, Ltd. | 07/17/2018SE |
| K173556 | Injection ScrewHWC · Traditional | Biedermann Medtech, Inc. | 07/13/2018SE |
| K180024 | SALVATION Midfoot NailHWC · Traditional | Wrightmedicaltechnologyinc | 07/11/2018SE |
| K180377 | Fracture and Correction SystemHWC · Traditional | In2bones USA, LLC | 06/20/2018SE |
| K180500 | VariAx 2 SystemHWC · Traditional | Stryker GmbH | 06/04/2018SE |
| K180932 | Diamond Orthopedic Bone Fixation Screws and PinsHWC · Special | Diamond Orthopedic, LLC | 05/09/2018SE |
| K180257 | InCore® Lapidus SystemHWC · Traditional | Nextremity Solutions, Inc. | 04/25/2018SE |
| K180753 | SafetyFix EasyOut SystemHWC · Special | Safetyfix Medical Technologies, Inc. | 04/20/2018SE |
| K173710 | MotoBAND CP Implant SystemHWC · Special | Crossroads Extremity Systems, LLC | 02/12/2018SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2361-2026 Class II | Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated…The cannulation of the CCS screw is not centered. | Medartis AG | 04/24/2026Open, Classified |
| Z-1606-2026 Class II | HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | I.T.S. GmbH | 01/23/2026Open, Classified |
| Z-1599-2026 Class II | I.T.S. Screw System with the below descriptions and corresponding article numbers. 1.…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | I.T.S. GmbH | 01/23/2026Open, Classified |
| Z-1550-2026 Class II | Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number:…Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | Medartis AG | 01/09/2026Open, Classified |
| Z-1549-2026 Class II | Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number:…Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | Medartis AG | 01/09/2026Open, Classified |
| Z-0957-2026 Class II | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.Removal of affected lot of screws due to labeling error. | Smith & Nephew, Inc. | 11/24/2025Open, Classified |
| Z-1821-2024 Class II | APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the…Screw is 16mm long instead of 22mm long. | Medartis Inc. | 04/12/2024Open, Classified |
| Z-1729-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1728-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1727-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1726-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1725-2024 Class II | ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1724-2024 Class II | ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1723-2024 Class II | ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1722-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1721-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1720-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1719-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1718-2024 Class II | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1717-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1716-2024 Class II | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1715-2024 Class II | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1714-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1713-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1712-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1711-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1710-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1709-2024 Class II | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4…Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The… | Zimmer, Inc. | 03/20/2024Open, Classified |
| Z-1792-2024 Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only…Nail system contains an out of specification driver-socket which could result in inability to pick up nails… | TriMed Inc. | 03/19/2024Open, Classified |
| Z-1791-2024 Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only…Nail system contains an out of specification driver-socket which could result in inability to pick up nails… | TriMed Inc. | 03/19/2024Open, Classified |
| Z-1320-2024 Class II | I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180This Field Action is being conducted following the identification of a batch mix-up between I.B.S… | In2Bones, SAS | 01/26/2024Open, Classified |
| Z-1319-2024 Class II | I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175This Field Action is being conducted following the identification of a batch mix-up between I.B.S… | In2Bones, SAS | 01/26/2024Open, Classified |
| Z-0770-2023 Class II | Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak…Distribution without Pre-Market Clearance | Acumed LLC | 11/29/2022Open, Classified |
| Z-0769-2023 Class II | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm…Distribution without Pre-Market Clearance | Acumed LLC | 11/29/2022Open, Classified |
| Z-0768-2023 Class II | Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw 30-0021-S…Distribution without Pre-Market Clearance | Acumed LLC | 11/29/2022Open, Classified |
| Z-0767-2023 Class II | Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S…Distribution without Pre-Market Clearance | Acumed LLC | 11/29/2022Open, Classified |
| Z-0959-2022 Class II | 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the… | Acumed LLC | 03/09/2022Completed |
| Z-0958-2022 Class II | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the… | Acumed LLC | 03/09/2022Completed |
| Z-0914-2022 Class II | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrumentProximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | Nextremity Solutions | 02/10/2022Terminated |
| Z-0913-2022 Class II | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | Nextremity Solutions | 02/10/2022Terminated |
| Z-0912-2022 Class II | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | Nextremity Solutions | 02/10/2022Terminated |
| Z-0911-2022 Class II | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | Nextremity Solutions | 02/10/2022Terminated |
| Z-0910-2022 Class II | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | Nextremity Solutions | 02/10/2022Terminated |
| Z-0740-2022 Class II | Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone…During insertion of the middle phalanx implant into bone, the driver may deform the implant locking… | Nextremity Solutions | 01/13/2022Terminated |
| Z-0739-2022 Class II | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone…During insertion of the middle phalanx implant into bone, the driver may deform the implant locking… | Nextremity Solutions | 01/13/2022Terminated |
| Z-0453-2022 Class II | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, SterileThe firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length… | Medshape, INC. | 11/17/2021Open, Classified |
| Z-1361-2022 Class II | ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605Mislabeled product. | Science & Bio Materials | 10/07/2021Completed |
| Z-0143-2022 Class II | 6.5MMX165MM CANNULATED SCREWThe product label incorrectly indicated that the screws are fully threaded, but the screws contained in the… | Smith & Nephew, Inc. | 09/20/2021Terminated |
| Z-1501-2021 Class II | InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage:…Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not… | Nextremity Solutions | 03/26/2021Terminated |
| Z-1500-2021 Class II | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage:…Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not… | Nextremity Solutions | 03/26/2021Terminated |