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The Orthopeasia Spinal Fixation System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: - Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies): - Degenerative spondylolisthesis with objective evidence of neurologic impairment; - Trauma (i.e., fracture or dislocation); - Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); - Tumor; - Stenosis; - Failed previous fusion (pseudarthrosis) The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.

The Orthopeasia Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The system consists of a variety of shapes and sizes of screws, rods, crosslinks and connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine. The Orthopeasia Spinal Fixation System is this submission comprises of the following components, A. Pedicle screws (Mono-axial and Poly-axial), standard, cannulated, with: - a. Monoaxial screw diameters from 5.5mm to 8.5mm - b. Polyaxial screw diameters from 5.5mm to 8.5mm - c. Monoaxial length range from 20mm to 55mm - d. Polyaxial length range from 20mm to 100mm - e. Made up of titanium alloy (ASTM F136). - B. Straight rods of diameter of 5.0 mm made up of cobalt chrome alloy (ASTM F1537) - C. Crosslinks and connectors made up of titanium alloy (ASTM F136).