510(k) Report

Devices descending from K123241

71 later devices reach Arthrex Fracture Plates through their predicates, nearest generation first.

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