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The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications: - Degenerative Disc Disease (as defined by neck pain of the discogenic origin with . degeneration of disc confirmed by patient history and radiographic studies) - Trauma (including fractures) . - Tumors . - Deformities or curvatures (including kyphosis, lordosis, or scoliosis) . - Pseudarthrosis . - . Failed previous fusion - . Spondylolisthesis - . Spinal Stenosis

The GPS™ G Surgical Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, bone screws, locking screws, and associated instruments. Fixation is provided by bone screws, of various lengths, inserted into the vertebral body of the cervical spine using an anterior approach. The GPS™ G Surgical Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and supplied non sterile. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the GPS ™, G Surgical Pedicle System implants.

The GPS ™, G Surgical Pedicle System is a pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the GPS ™, G Surgical Pedicle 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). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the GPS ™, G Surgical Pedicle System is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The GPS ™, G Surgical Pedicle System is a top-loading anterior / posterior spinal fixation system which consists of Mono and Polyaxial pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The GPS ™ implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The GPS ™, G Surgical Pedicle System can be used in both the anterior and posterior planes providing unilateral and bilateral modes of fixation. The GPS ™, G Surgical Pedicle System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled washer in the housing component between screw and the rod which tightens against the head of the pedicle screw upon connection of the set screw with the rod. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the GPS ™, G Surgical Pedicle System implants.