The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism. The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System. The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI 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.
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
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