Search Results

The MEGAFIX(R) Pedicle Screw Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the lumbar and sacral spine for 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 (Grade 1 and 2) of the L5-S1; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The MEGAFIX® Pedicle Screw Spinal System is used for posterior, non-cervical pedicle fixation of the lumbar and sacral spine. This system is comprised of monoaxial screws, monoaxial reduction screws, polyaxial screws, polyaxial reduction screws, polyaxial cannulated screws, cannulated reduction screws, straight rods, set screws, and transverse link. All components are supplied non-sterile, single use and made from Titanium Alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various types and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The MEGAFIX® Pedicle Screw Spinal System is delivered non-sterile and sterilization instructions are provided. The principle of the spinal fixation is based on pedicle screw-rod locking systems, with the rods transversely crosslinked. A combination of pedicle screws and rods creates a solid "brace" that holds spinal segments. Pedicle screws are fixed through the pedicle bone on the posterior spinal column. The pedicle screw is inserted through the pedicle and into the vertebral body, one on each side. The pedicle screws fix to the bone of the vertebral body, giving them a good solid hold on the vertebrae. Once the pedicle screws are implanted, they are attached to rods that connect all the pedicle screws together. When all components are bolted and tightened by set screws, a stiff metal frame that holds vertebrae still is created so that fusion can occur. Bone graft is then placed around the posterior vertebrae at the implant. A transverse link is used to connect two substantially parallel longitudinal rods for improved stability in the surgical treatment and for increased rotational stiffness for the final construct.