510(k) Report

Devices descending from K101437

12 later devices reach Speedfix Suture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112453Sterispineps Pedicle ScrewSafe Orthopaedics201110—
+1K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low…Arthrocare Corp.20110—
+2K201648Sterispine™ PSSafe Orthopaedics202011
+2K171582NEO Pedicle Screw System™Neo Medical SA20170—
+2K170528Sterispine™ PSSafe Orthopaedics20172—
+2K151921Sterispine PSSafe Orthopaedics20153—
+2K151747Sterispine PSSafe Orthopaedics20153—
+2K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+2K140802Sterispine PSSafe Orthopaedics20144—
+2K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+2K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—