Search Results

The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The SHARK implant (PLIF) consists of rectangular blocks with a tapered nose. The BULLSHARK implant (PLIF) is rectangular in shape with a conical nose. Both devices have parallel configurations of various heights. The TIGER implant (TLIF) consists of banana shaped blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft and facilitate fusion. The GREAT WHITE implants (ALIF) are oval shaped blocks, which are available in a two lordotic configurations (7° and 13°) of various heights. The hollow cylinders allow for placement of bone graft and facilitate fusion. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing applications.

The Black Widow Anterior Buttress Plate is designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Specific system features include: Plate uniquely shaped to conform to anterior spine anatomy. Two peas which engage the vertebral body and prevent rotation. An extremely low profile plate with a full radius around the perimeter and a screw that sits flush with the anterior surface of the staple. A self-tapping screw in multiple lengths. The devices are manufactured from Ti6Al4V per ASTM F136. The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.