510(k) Report

Devices descending from K041356

247 later devices reach Arthrex Tenodesis Screw Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173746Activmotion RangeNewclip Technics20181—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K162198GFS UltimateParcus Medical, LLC20168—
+4K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+4K133275Mini TightropeArthrex, Inc.201411—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K111032CMC Cable FixInstratek, Inc.20112—
+5K261511Xpert AnkleNewclip Technics20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K202307Activ FuseNewclip Technics20200—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+5K183331Parcus GFS BTBParcus Medical, LLC20193—
+5K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K160655OrthoButton CLRiverpoint Medical20169—
+5K152711Parcus GFS NakedParcus Medical, LLC20154—
+5K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+6K254280F.A.S.T ScrewSteps Ortho20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K254215Arthrex Beaming SystemArthrex, Inc.20261—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+6K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+6K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—