Search Results

The Fidji Small Cement Restrictor is intended for use in conjunction with standard PMMA cement and is designed to occlude the medullary canal during the introduction of the cement during surgeries such as arthroplasty. It is also designed to prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

The Fidji Small Cement Restrictor is a hollow, trapezoidal block that is machined from cxtruded Polyetherctherketone (PEEK), which complies with ASTM F202. It contains a titanium alloy, removable anchor that is designed to aid in maintaining its position within the medullary space of the femur or humerus. It also contains tantalum inserts that serve as location and orientation markers for radiographs.

When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used as a pedicle screw fixation system, the JAVA Spinal Fixation System is also 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Spine Next SHIRAZ JAVA Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after development of a solid fusion mass. The system includes screws, rods, and connectors. All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.