510(k) Report

Devices descending from K070925

57 later devices reach Modification to: Bioknotless BR Anchor / Lupine BR Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+1K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+1K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Smith & Nephew, Inc.201110—
+1K081172Composite Hitch Suture AnchorBiomet Manufacturing Corp20080—
+1K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+2K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+2K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+2K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+2K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+2K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.20184—
+2K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+2K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+2K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+2K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+2K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+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—
+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
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+3K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+3K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+3K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+3K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+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—
+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—
+4K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+4K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+4K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+4K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+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—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+5K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+5K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+5K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+6K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—