510(k) Report

Devices descending from K922559

349 later devices reach Acufex Endofix Button through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K202399OrthoButton FLRiverpoint Medical20201—
+6K193575Arthrex SutureTapeArthrex, Inc.20201—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K192984APTUS Clavicle SystemMedartis AG20206—
+6K190143LARS AC Band DeviceCorin USA20191—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+6K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+6K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+6K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+6K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+6K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+6K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+6K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+6K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+6K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+7K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K243469SignexOsteonic Co., Ltd.20250—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+7K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+7K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+7K202307Activ FuseNewclip Technics20200—
+7K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+7K191972ARIX Wrist SystemJeil Medical Corporation20190—
+7K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+7K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+7K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+7K132502Variax 2 SystemStryker Trauma AG201321—
+7K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+8K254280F.A.S.T ScrewSteps Ortho20260—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K254215Arthrex Beaming SystemArthrex, Inc.20261—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+8K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+8K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320