510(k) Report

Devices descending from K071177

227 later devices reach Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192—
+1K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192—
+1K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+1K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+1K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+1K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+1K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+1K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009100—
+1K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2009159—
+1K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+2K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261—
+2K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+2K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+2K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241—
+2K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+2K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+2K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+2K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+2K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+2K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials20172—
+2K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+2K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+2K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+2K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.201463—
+2K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+2K112237Microsuture AnchorsArthrex, Inc.201177—
+2K110660Arthrex Biocomposite SuturetakArthrex, Inc.201164—
+2K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+2K101823Arthrex Swivelock AnchorsArthrex, Inc.20111036
+2K101679Arthrex Pushlock AnchorsArthrex, Inc.201041—
+2K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+2K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+3K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+3K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+3K260018Arthrex FiberButtonArthrex, Inc.20260—
+3K260294SF Push-in AnchorSurgical Fusion Technologies GmbH20260—
+3K253538TeKBrace Knotless AnchorTheramicro20260—
+3K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+3K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+3K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252—
+3K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250—
+3K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+3K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+3K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+3K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+3K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+3K231787ecoFIX®Science & Bio Materials (S.B.M.) Sas20230—
+3K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+3K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+3K220966SinefixBAAT Medical Products B.V.20231—
+3K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+3K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+3K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+3K203493MectaLock ExtensionMedacta International S.A.20210—
+3K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+3K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+3K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+3K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+3K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+3K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+3K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+3K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+3K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+3K180759SECULOK™ Suture AnchorU&I Corporation20180—
+3K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials20181—
+3K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+3K173269KATOR Suture AnchorKator, LLC20182—
+3K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+3K173240Arthrex PushLockArthrex, Inc.20182—
+3K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+3K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+3K152255BoneCam Suture AnchorsValeris Medical20151—
+3K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+3K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+3K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+3K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+3K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+3K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+3K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+3K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+3K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+3K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+3K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+4K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+4K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K254176SinefixBAAT Medical Products B.V.20260—