510(k) Report

Devices descending from K141735

38 later devices reach Arthrex Ankle Fusion Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+1K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+1K202307Activ FuseNewclip Technics20200—
+1K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+1K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+1K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+1K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+1K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+1K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+1K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+2K254215Arthrex Beaming SystemArthrex, Inc.20261—
+2K252246Leforte MMF SystemJeil Medical Corporation20260—
+2K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+2K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+2K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+2K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+2K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+2K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+2K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+2K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K262975Arthrex Beaming SystemArthrex, Inc.20260—
+3K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+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—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—