510(k) Report

Devices descending from K090615

18 later devices reach Opus Speedlock Knotless Fixation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111044Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile…ArthroCare Corporation20114—
+1K101437Speedfix Suture SystemArthrocare Corp.201012—
+2K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp…Arthrocare Corp.20131—
+2K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+2K112453Sterispineps Pedicle ScrewSafe Orthopaedics201110—
+2K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low…Arthrocare Corp.20110—
+3K201648Sterispine™ PSSafe Orthopaedics202011
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K170528Sterispine™ PSSafe Orthopaedics20172—
+3K153313SpeedLock Knotless Fixation SystemArthroCare Corporation20150—
+3K151921Sterispine PSSafe Orthopaedics20153—
+3K151747Sterispine PSSafe Orthopaedics20153—
+3K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+3K140802Sterispine PSSafe Orthopaedics20144—
+3K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+3K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+3K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—