510(k) Report

Devices descending from K061349

50 later devices reach Opus Labralock P Knotless Fixation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120096Multifix P Knotless Fixation DeviceArthroCare Corporation201211—
+1K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+1K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp.2009181
+1K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp.200727—
+2K151897MultiFIX® P Knotless Fixation DeviceArthroCare Corporation20150—
+2K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+2K111044Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile…ArthroCare Corporation20114—
+2K101437Speedfix Suture SystemArthrocare Corp.201012—
+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—
+2K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+3K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp…Arthrocare Corp.20131—
+3K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+3K112453Sterispineps Pedicle ScrewSafe Orthopaedics201110—
+3K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low…Arthrocare Corp.20110—
+3K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+3K101448Opus Speedscrew SystemArthrocare Corp.2010101
+3K100457Opus Speedscrew SystemArthrocare Corp.201015—
+3K091870Tornier, Piton Fixation Implant SystemTornier20096—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K171582NEO Pedicle Screw System™Neo Medical SA20170—
+4K170528Sterispine™ PSSafe Orthopaedics20172—
+4K153313SpeedLock Knotless Fixation SystemArthroCare Corporation20150—
+4K151921Sterispine PSSafe Orthopaedics20153—
+4K151747Sterispine PSSafe Orthopaedics20153—
+4K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+4K140802Sterispine PSSafe Orthopaedics20144—
+4K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+4K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+4K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+4K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+4K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+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—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+5K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+5K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+5K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+5K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+6K253538TeKBrace Knotless AnchorTheramicro20260—
+6K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—