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The Preference Elite Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows: The Preference Elite System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: 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., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. In addition, when used as a pedicle screw fixation system, the Preference Elite Pedicle Screw System is indicated for skeletally matures patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.

The Preference Elite Pedicle Screw System is a spinal fixation system consisting of a variety of components including screws, various types and sizes of rods, cross-connectors and accessories, as well as implant components from the Preference Pedicle Screw System. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient. Implant components from the Preference Pedicle Screw System including the curved and straight rods, set-screws, and cross-connectors are compatible with the Preference Elite Pedicle Screw System. The Preference Elite Pedicle Screw System implants and components are made from titanium alloy (Ti-6A1-4V) per ASTM F136 and Cobalt-28 Chromium-6 Molybdenum Alloy (Co-28Cr-6Mo) per ASTM F1537.