510(k) Report

Devices descending from K061863

283 later devices reach Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+4K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+4K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+4K231787ecoFIX®Science & Bio Materials (S.B.M.) Sas20230—
+4K231326Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.20231—
+4K223284SutureLoc™ ImplantArthrex, Inc.20230—
+4K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+4K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+4K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+4K212739ActiFlipParcus Medical, LLC20210—
+4K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+4K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+4K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+4K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+4K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+4K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials20181—
+4K171465Stryker Self-Punching ICONIXStryker20171—
+4K170098ICONIX TT All Suture AnchorStryker20173—
+4K160319FiberTak DRArthrex, Inc.20160—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K151201Stryker ICONIX with NeedlesStryker201510—
+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—
+4K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+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—
+4K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+4K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+4K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+5K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+5K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+5K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+5K230568FiberTak Suture AnchorArthrex, Inc.20236—
+5K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+5K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+5K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+5K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K172921Stryker Self-Punching ICONIXStryker20170—
+5K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+5K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+5K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+6K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+6K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+6K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+6K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+6K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K233468Iconix AnchorRiverpoint Medical20231—
+7K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—