510(k) Report

Devices descending from K952535

348 later devices reach Acufex Endobutton Tape through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261511Xpert AnkleNewclip Technics20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+6K254182AsterOsteonic Co., Ltd.20260—
+6K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K243469SignexOsteonic Co., Ltd.20250—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+6K241539Activmotion SNewclip Technics20240—
+6K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K240194ProCinch, QuadCinchRiverpoint Medical20240—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K233552IDEAL ZiploopRiverpoint Medical20230—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+6K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+6K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+6K230212OrthoButton ALRiverpoint Medical, LLC20232—
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K221354Arthrex SutureTapeArthrex, Inc.20220—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+6K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+6K202307Activ FuseNewclip Technics20200—
+6K202399OrthoButton FLRiverpoint Medical20201—
+6K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+6K193575Arthrex SutureTapeArthrex, Inc.20201—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K191972ARIX Wrist SystemJeil Medical Corporation20190—
+6K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+6K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+6K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+6K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+6K132502Variax 2 SystemStryker Trauma AG201321—
+6K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+7K254280F.A.S.T ScrewSteps Ortho20260—
+7K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+7K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+7K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K254215Arthrex Beaming SystemArthrex, Inc.20261—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+7K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+7K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+7K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+7K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+7K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—