510(k) Report

Devices descending from K012125

105 later devices reach Opus Magnum Anchor & Inserter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp.200727—
+1K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc.2004523
+1K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc.200455—
+1K020172Opus Magnum Anchor & Instrument SetOpus Medical, Inc.20020—
+2K091503Magnum MP Fixation DeviceArthrocare Corp.20090—
+2K083240Opus MAGNUM2 and Opus Magnum X Knotless Fixation DevicesArthrocare Corp.200903
+2K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.200816—
+2K081497Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X Knotless Fixation…Arthrocare Corp.20080—
+2K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—
+2K071374Opus Twinlock Knotless Fixation DeviceArthrocare Corp.20070—
+2K061294KFX Knotless Fixation SystemKfx Medical200619—
+2K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.200650—
+2K060914Trident AnchorJohnson & Johnson Company200633—
+3K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+3K120096Multifix P Knotless Fixation DeviceArthroCare Corporation201211—
+3K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+3K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+3K101448Opus Speedscrew SystemArthrocare Corp.2010101
+3K100457Opus Speedscrew SystemArthrocare Corp.201015—
+3K100532Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819Depuy Mitek, A Johnson & Johnson Company20100—
+3K091870Tornier, Piton Fixation Implant SystemTornier20096—
+3K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp.2009181
+3K072063KFX Tissue Fixation System and AccessoriesKfx Medical200718—
+3K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Depuy Mitek, A Johnson & Johnson Company200632—
+4K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+4K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+4K171020Arthrex Knotless SutureTak AnchorArthrex, Inc.201727—
+4K151897MultiFIX® P Knotless Fixation DeviceArthroCare Corporation20150—
+4K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+4K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+4K111044Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile…ArthroCare Corporation20114—
+4K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+4K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+4K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+4K101437Speedfix Suture SystemArthrocare Corp.201012—
+4K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+4K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical200816—
+4K0802295.5 MM Suture Lock Bone Screw AnchorKfx Medical20080—
+5K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+5K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+5K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+5K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+5K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+5K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+5K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+5K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp…Arthrocare Corp.20131—
+5K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+5K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+5K112453Sterispineps Pedicle ScrewSafe Orthopaedics201110—
+5K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low…Arthrocare Corp.20110—
+5K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+6K253538TeKBrace Knotless AnchorTheramicro20260—
+6K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+6K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+6K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+6K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+6K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+6K230568FiberTak Suture AnchorArthrex, Inc.20236—
+6K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+6K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+6K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+6K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+6K201648Sterispine™ PSSafe Orthopaedics202011
+6K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+6K180759SECULOK™ Suture AnchorU&I Corporation20180—
+6K171582NEO Pedicle Screw System™Neo Medical SA20170—
+6K170528Sterispine™ PSSafe Orthopaedics20172—
+6K153313SpeedLock Knotless Fixation SystemArthroCare Corporation20150—
+6K151921Sterispine PSSafe Orthopaedics20153—
+6K151747Sterispine PSSafe Orthopaedics20153—
+6K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+6K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+6K140802Sterispine PSSafe Orthopaedics20144—
+6K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+6K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+6K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+6K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+7K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+7K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+7K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+7K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+7K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+7K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+7K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—
+7K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+7K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+7K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+7K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+7K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—