510(k) Report

Devices descending from K061863

283 later devices reach Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K101448Opus Speedscrew SystemArthrocare Corp.2010101
+2K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+2K100457Opus Speedscrew SystemArthrocare Corp.201015—
+2K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009100—
+2K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+2K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2009159—
+2K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+3K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+3K251750Trax EX AnchorTrax Surgical, Inc.20260—
+3K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+3K260405FiberTape ButtonArthrex, Inc.20260—
+3K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+3K253695LigaMendRiverpoint Medical, LLC20260—
+3K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+3K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+3K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+3K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+3K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+3K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.20254—
+3K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+3K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+3K243988RootMend MRRRiverpoint Medical, LLC20250—
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+3K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241—
+3K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+3K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+3K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+3K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+3K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.20231—
+3K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+3K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+3K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+3K220966SinefixBAAT Medical Products B.V.20231—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K213958Bioabsorbable AnchorEmbody, Inc.20220—
+3K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+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—
+3K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+3K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+3K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+3K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+3K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+3K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+3K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+3K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+3K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+3K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+3K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+3K173845Arthrex SwiveLockArthrex, Inc.20188—
+3K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+3K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+3K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials20172—
+3K172612FiberTak DXArthex, Inc.20170—
+3K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+3K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+3K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+3K151230Arthrex FiberTak AnchorsArthrex, Inc.201527—
+3K133671Iconix All Suture AnchorsStryker Corp.201425—
+3K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+3K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+3K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+3K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+3K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+3K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+3K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+3K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+3K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+3K110660Arthrex Biocomposite SuturetakArthrex, Inc.201164—
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+3K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+3K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+3K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+4K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—
+4K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.20260—
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K260294SF Push-in AnchorSurgical Fusion Technologies GmbH20260—
+4K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+4K254176SinefixBAAT Medical Products B.V.20260—
+4K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+4K253040Aevumed FASE Suture AnchorAevumed, Inc.20253—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+4K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+4K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+4K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20240—
+4K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+4K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—