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The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor: pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft. The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients: Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

The DSS™ Stabilization System -- Rigid is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V). This submission presents the addition of a 20mm long rigid coupler.