Search Results

The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft, having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Mega 5.5 Spine 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The MEGA5.5 Spine System is a top-loading multiple component, posterior spinal fixation systems which consists of pedicle screws (mono, long-arm, multi-axial long-arm screw), rods, locking bolt, and a transverse linking mechanism (cross-link). The M EGA5.5 Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA5.5 Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA 5.5 Spine System.