Bone-screw internal spinal fixation system, non-sterile

Intended purpose

The DIPLOMAT Spinal System, when used as a posterior pedicle screw system, 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 the thoracic, lumbar and sacral spine: - Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Spinal stenosis - Fracture - Dislocation - Scoliosis - Kyphosis - Spinal tumor - Pseudoarthrosis - Failed previous fusion In addition, the DIPLOMAT Spinal System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. The DIPLOMAT Spinal System is intended to be used with autograft and/or allograft.