510(k) Report

Devices descending from K021556

80 later devices reach Synthes 2.4 MM Cannulated Compression Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190830TDM Screw SystemsTdm Co., Ltd.20191—
+1K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH20180—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+1K143165Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…Zimmer, Inc.201572
+1K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+1K133842Tyber Medical Trauma ScrewTyber Medical, LLC201423—
+1K112737Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd.2011124
+1K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+1K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K253042Tyber Medical Trauma ScrewTyber Medical, LLC20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K231860TDM Screw SystemTdm Co., Ltd.20240—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc.20221—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+2K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+2K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+2K192974Tyber Medical Trauma ScrewTyber Medical, LLC20201—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K181898Two-Step Implant SystemTrilliant Surgical20180—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K170571Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix ScrewTyber Medical, LLC20170—
+2K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P.20162—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K153575Tyber Medical Trauma ScrewTyber Medical, LLC201612—
+2K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+2K153180Tyber Medical MST Trauma ScrewTyber Medical, LLC20152—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+2K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K252901Tyber Medical Trauma ScrewTyber Medical, LLC20250—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K230908Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc.20230—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC20161—
+4K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—