510(k) Report

Devices descending from K091844

100 later devices reach Arthrex Bio-Composite Suturetak Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.201463—
+1K112237Microsuture AnchorsArthrex, Inc.201177—
+1K110660Arthrex Biocomposite SuturetakArthrex, Inc.201164—
+1K101679Arthrex Pushlock AnchorsArthrex, Inc.201041—
+2K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261—
+2K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+2K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252—
+2K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+2K241695Extremity All Suture SystemField Orthopaedics20240—
+2K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+2K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+2K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+2K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+2K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+2K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K203493MectaLock ExtensionMedacta International S.A.20210—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+2K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+2K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192—
+2K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192—
+2K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+2K180759SECULOK™ Suture AnchorU&I Corporation20180—
+2K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+2K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+2K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+2K173240Arthrex PushLockArthrex, Inc.20182—
+2K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+2K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+2K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+2K152255BoneCam Suture AnchorsValeris Medical20151—
+2K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+2K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+2K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+3K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+3K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+3K251750Trax EX AnchorTrax Surgical, Inc.20260—
+3K253538TeKBrace Knotless AnchorTheramicro20260—
+3K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+3K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+3K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+3K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.20254—
+3K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+3K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+3K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+3K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.20231—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+3K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20212—
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+3K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+3K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+3K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+3K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+3K172612FiberTak DXArthex, Inc.20170—
+3K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K151230Arthrex FiberTak AnchorsArthrex, Inc.201527—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.20260—
+4K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+4K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+4K253040Aevumed FASE Suture AnchorAevumed, Inc.20253—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20240—
+4K231326Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.20231—
+4K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+4K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+4K160319FiberTak DRArthrex, Inc.20160—
+5K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+5K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+5K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+5K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+5K230568FiberTak Suture AnchorArthrex, Inc.20236—
+5K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+6K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+6K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+6K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+6K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+7K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—