The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograph. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The Ballista Instruments are intended to be used with the 5.5 Polaris implants. The Ballista Instruments, when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.
The AccuVision Instruments, when used with the Polaris Spinal System are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system.
Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The AccuVision Illuminated Blade Tip is intended for the illumination of surgical procedures and exclusively for use with the AccuVision retractor frame.
The dominoes in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet® Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system’s Package Insert for a list of the indications for use for each system.
The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery and is intended for use as part of either a single or double rod assembly. It allows for distraction at a central location once bone anchors have been secured.
The Bullet End Rods are intended for use with the Jackson Intrasacral Fixation Technique.
The AccuVision Illuminated Blade Tip is a sterile, single use, latex free, plastic fiber optic device intended to bring cool area lighting into spinal surgeries. The AccuVision Illuminated Blade Tip is intended for use with a 300 watt xenon illuminator, using a 3mm fiber optic cable with a female ACMI connector.