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The GII Spinal Fixation System using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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; and (d) who are having the device removed after the development of a solid fusion mass. The levels of pedicle screw fixation may be from L3 to the sacrum.

The GII Spinal Fixation System is available in stainless steel and titanium alloy and includes plates, screws and optional spacers. Plates are offered in a variety of lengths (41.1 to 141.2mm) and have longitudinal openings to accommodate the mechanical thread portion of the screw. Screws are have both cancellous and mechanical threads, and are available with mechanical thread lengths of 27 or 12mm, cancellous thread lengths ranging from 37 to 52mm in 5mm increments and cancellous thread outer diameters ranging from 5.5 to 8.5mm. Optional spacers are available in 3 or 5mm heights or in a 1.5 to 5mm angled height.