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The Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. The Pillar Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spinc: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture. spinal stenosis, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

The Pillar Pedicle Screw System is an internal fixation device for spinal surgery consisting of pedicle screws and rods that are interconnected using crosslinks and set screws. To chable close conformance to patient anatomy, pedicle screws and rods are available in various lengths, diameters, and/or contours. A series of manual surgical instruments (not a subject of this submission) intended to assist the insertion and placement of the implants are provided in an instrument tray.