510(k) Report

Devices descending from K013572

117 later devices reach Mitek Biocryl Interference Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company20091—
+1K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company20092—
+1K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd.20080—
+1K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+1K032717Biocryl Rapide Interference ScrewMitek Worldwide2004107—
+1K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide200315—
+2K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+2K123362Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20135—
+2K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+2K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+2K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118—
+2K093912Arthrex Tibial GraftboltArthrex, Inc.20103—
+2K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+2K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747—
+2K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company20077—
+2K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006103—
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+3K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+3K180662Arthrex FastThread Interference ScrewArthrex, Inc.20183—
+3K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+3K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+3K161174Nanova Interference ScrewNanova Biomaterials, Inc.20160—
+3K160804INTRAFIX (TM) Advance Tibial Fastener SystemMedos International SARL20160—
+3K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+3K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+3K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+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—
+3K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company20125—
+3K120540BioboltArthrex, Inc.20120—
+3K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+3K110123PCL TightropeArthrex, Inc.20118—
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K103060Arthrex Tibial GraftboltArthrex, Inc.20112—
+3K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+3K102443Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company20100—
+3K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+3K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+3K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+4K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+4K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K203335MectaScrew ExtensionMedacta International S.A.20220—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K202535Arthrex FastThread Interference ScrewArthrex, Inc.20202—
+4K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+4K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+4K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K173845Arthrex SwiveLockArthrex, Inc.20188—
+4K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+4K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+4K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+4K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+4K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+4K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K223284SutureLoc™ ImplantArthrex, Inc.20230—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+5K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+5K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+5K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+6K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—