SETx - Pedicle Screw System

The SETx Pedicle Screw System is an internal spinal fixation system comprised of longitudinal rods and polyaxial screws. All implant components of the SETx Pedicle Screw System are made of Titanium Alloy, Ti6Al4V and Cobalt-Chromium Molybdenum. The SETx Pedicle Screw System is a sterile packaged, single-use spinal system. The SETx Pedicle Screw System has been approved for posterior, non-cervical pedicle fixation or anterolateral fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); curvatures (i.e., scoliosis, kyphosis, or lordosis); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.