510(k) Report

Devices descending from K062170

58 later devices reach Bioknotless and Lupine Plus Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070925Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company20075711
+2K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+2K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+2K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Smith & Nephew, Inc.201110—
+2K081172Composite Hitch Suture AnchorBiomet Manufacturing Corp20080—
+2K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+3K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+3K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+3K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.20184—
+3K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+3K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+3K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+3K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+3K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+3K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+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—
+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
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+4K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+4K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+4K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+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—
+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—
+4K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+4K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+5K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+5K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+5K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+5K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+5K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+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—
+6K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+6K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+6K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+6K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+6K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+7K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—