510(k) Report

Devices descending from K042914

55 later devices reach Opus Magnum Knotless Anchor with Inserter Handle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081497Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X Knotless Fixation…Arthrocare Corp.20080—
+1K061294KFX Knotless Fixation SystemKfx Medical200619—
+1K060914Trident AnchorJohnson & Johnson Company200633—
+2K100532Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819Depuy Mitek, A Johnson & Johnson Company20100—
+2K072063KFX Tissue Fixation System and AccessoriesKfx Medical200718—
+2K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Depuy Mitek, A Johnson & Johnson Company200632—
+3K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+3K171020Arthrex Knotless SutureTak AnchorArthrex, Inc.201727—
+3K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+3K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical200816—
+3K0802295.5 MM Suture Lock Bone Screw AnchorKfx Medical20080—
+4K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+4K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+4K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+4K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+4K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+4K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+5K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+5K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+5K230568FiberTak Suture AnchorArthrex, Inc.20236—
+5K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+5K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+5K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+6K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+6K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+6K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+6K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+6K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+6K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+6K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+6K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+6K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+6K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+6K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+7K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—