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The mont blanc system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral/iliac spine. This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients: · 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; - · deformities (i.e., scoliosis, kyphosis, and/or lordosis); - · spinal tumor, - · pseudoarthrosis; and - · failed previous fusion. The mont blanc system is intended to be used with autograft and/or allograft. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The mont blanc MIS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients: · 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; - · deformities (i.e., scoliosis, kyphosis, and/or lordosis); - · spinal tumor, - · pseudoarthrosis; and - · failed previous fusion. The mont blanc MIS system is intended to be used with autograft and/or allograft. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.

The Spineway mont blanc & mont blanc MIS Spinal Systems are implant device systems comprised of a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The fenestrated screws are polyaxial screws in diameters from 5.0 – 8.0 mm and in lengths from 30 – 55 mm. 6 fenestration holes are present in screws of length 35 mm or longer, 3 fenestration holes are present in screws of length 30 mm. Dual connectors and domino connectors are available to connect 2 parallel rods together, lliac lateral connectors are available to create an Iliac fixation, and Axial connectors are available to connect 2 coaxial rods together. Associated instrumentation to complete the procedure is provided reusable and non-sterile.