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The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine. It is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation. The Spinal Fusion Cage System is single component devices used to restore height of disc and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device made withh PEEK Polymer has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026 & Titanium Ti6Al4V Eli ASTM F136) to promote biological synostosis and assures mechanical safety against load.

The 4CIS SARA Spine System and 4CIS VERTU Spine System is a pedicle screw system indicated for the weathern 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 4CIS SARA Spine System and 4CIS VERTU Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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, spinal tumor and failed previous fusion (pseudarthrosis).

The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium alloy that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.