510(k) Report

Devices descending from K112437

91 later devices reach Arthrex Fracture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+1K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+1K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K143139Arthrex Fracture SystemArthrex, Inc.20151—
+1K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+2K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+2K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+2K230546SignexOsteonic Co., Ltd.20242—
+2K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+2K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200226RetroFixRetrofix Screws, LLC20200—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+2K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+2K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+2K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+2K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K261511Xpert AnkleNewclip Technics20260—
+3K254182AsterOsteonic Co., Ltd.20260—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K243469SignexOsteonic Co., Ltd.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+3K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+3K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+3K202307Activ FuseNewclip Technics20200—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+3K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+3K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—