510(k) Report

Devices descending from K050749

134 later devices reach Arthrex Tak Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153585Flip Button Suture AnchorFirst Ray, LLC20161—
+1K133229Titanium Suture AnchorMtp Solutions, LLC20142—
+1K0815112.0 PK Suture Anchor T, 2.0 PK Suture Anchor SSmith & Nephew, Inc.20083—
+1K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+1K063479Arthrex PushlockArthrex, Inc.200697—
+2K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261—
+2K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+2K233971Arthrex AlloSync PushLock Suture AnchorArthrex, Inc.20240—
+2K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241—
+2K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+2K220797FootHold SystemCrossroads Extremity Systems, LLC20220—
+2K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+2K191651Arthrex Nano SwiveLock Suture AnchorArthrex, Inc.20190—
+2K171228Fiji AnchorSportwelding GmbH20182—
+2K173240Arthrex PushLockArthrex, Inc.20182—
+2K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+2K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+2K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+2K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+2K143063Stryker SonicPin System, Stryker SonicAnchor SystemStryker Trauma GmbH20151—
+2K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+2K120509Stryker All Suture AnchorsStryker201227—
+2K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+2K112237Microsuture AnchorsArthrex, Inc.201177—
+2K111661Arthrex Scapholunate AnchorArthrex, Inc.20110—
+2K100532Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819Depuy Mitek, A Johnson & Johnson Company20100—
+2K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions20090—
+2K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+3K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+3K260294SF Push-in AnchorSurgical Fusion Technologies GmbH20260—
+3K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+3K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K220966SinefixBAAT Medical Products B.V.20231—
+3K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+3K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+3K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+3K170418Stryker SonicPin SystemStryker Trauma GmbH20170—
+3K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.201463—
+3K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+3K133671Iconix All Suture AnchorsStryker Corp.201425—
+3K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+4K254176SinefixBAAT Medical Products B.V.20260—
+4K251750Trax EX AnchorTrax Surgical, Inc.20260—
+4K253538TeKBrace Knotless AnchorTheramicro20260—
+4K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+4K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+4K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+4K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+4K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+4K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.20231—
+4K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+4K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+4K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+4K172612FiberTak DXArthex, Inc.20170—
+4K171465Stryker Self-Punching ICONIXStryker20171—
+4K170098ICONIX TT All Suture AnchorStryker20173—
+4K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+4K152255BoneCam Suture AnchorsValeris Medical20151—
+4K151201Stryker ICONIX with NeedlesStryker201510—
+4K151230Arthrex FiberTak AnchorsArthrex, Inc.201527—
+5K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.20260—
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.20254—
+5K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+5K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250—
+5K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+5K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+5K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+5K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20212—
+5K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+5K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+5K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+5K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+5K191426FiberTak ButtonArthrex, Inc.20190—