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The Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine 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 of the thoracic, lumbar, and/or sacral spine: degenerative disc disease (DDD) 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; curvatures (i.e., scollosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Mini-OSTEO Pedicle Fixation System consists of the following non-sterile, single-use components: monoaxial screws, polyaxial screws, rods, pedicle bars, laminar and transverse hooks, connectors, and a pedicle locking component for connectors. The connectors are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.