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The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: - Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies) - Spondvlolisthesis . - Trauma (i.e., fractures or dislocations) . - Tumors . - Deformity (defined as kyphosis, lordosis, or scollosis) . - Pseudoarthrosis . - Failed previous fusions .

The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

The Paramount™ Intervertebral Body Fusion Device is made of PEEK-OPTIMA®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The devices are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.

When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.

The IST Pedicle Screw System includes pedicle screws. polyaxial screw heads, locking caps and rods. The components are fabricated from titanium alloy (ASTM F-136). The system can be used in either percutaneous or open surgery procedures. The system components are provided clean and nonsterile for steam sterilization at the user's facility.