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When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the Procyon Spinal System is intended for 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: 1) degenerative spondylolisthesis with objective evidence of neurological impairment, 2) fracture, 3) dislocation, 4) scoliosis, 5) kyphosis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.

The Procyon Spinal System consists of polyaxial screws, rods, and connecting components. The components are fabricated from titanium alloy (ASTM F-136).