510(k) Report

Devices descending from K993975

118 later devices reach Absolute Absorbable Interference Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013572Mitek Biocryl Interference ScrewsMitek Products2002117—
+2K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company20091—
+2K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company20092—
+2K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd.20080—
+2K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+2K032717Biocryl Rapide Interference ScrewMitek Worldwide2004107—
+2K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide200315—
+3K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+3K123362Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20135—
+3K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+3K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+3K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+3K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118—
+3K093912Arthrex Tibial GraftboltArthrex, Inc.20103—
+3K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+3K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747—
+3K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company20077—
+3K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006103—
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+4K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+4K180662Arthrex FastThread Interference ScrewArthrex, Inc.20183—
+4K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+4K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+4K161174Nanova Interference ScrewNanova Biomaterials, Inc.20160—
+4K160804INTRAFIX (TM) Advance Tibial Fastener SystemMedos International SARL20160—
+4K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+4K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+4K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+4K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company20125—
+4K120540BioboltArthrex, Inc.20120—
+4K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+4K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+4K110123PCL TightropeArthrex, Inc.20118—
+4K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+4K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+4K103060Arthrex Tibial GraftboltArthrex, Inc.20112—
+4K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+4K102443Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company20100—
+4K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+4K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+4K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+5K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+5K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+5K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+5K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+5K203335MectaScrew ExtensionMedacta International S.A.20220—
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+5K202535Arthrex FastThread Interference ScrewArthrex, Inc.20202—
+5K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+5K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+5K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K173845Arthrex SwiveLockArthrex, Inc.20188—
+5K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+5K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+5K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+5K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+5K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+5K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+5K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+5K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+5K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+5K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+6K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+6K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+6K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K223284SutureLoc™ ImplantArthrex, Inc.20230—
+6K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+6K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+6K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+6K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+6K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—