Spinal fixation system - India CDSCO Medical Device Registration

Product Information

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 sys¬tem, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for all the following conditions: degenerative disc disease (Polaris 5.5 spinal system - Connector), spondylolisthesis, trauma, (Polaris 5.5 spinal system - Connector), deformity or curvature (Polaris 5.5 spinal system - Connector), tumor, stenosis, pseudoarthrosis, or failed previous fusion. The Ballista Instruments are intended to be used with the Ballista/Polaris 5.5 implants. Cannulated screws and percutaneous rods, may be used with the Ballista instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following above indications. For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adoles¬cent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach. The Polaris Spinal System may be used with the instruments in AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The dominos in the Polaris Spinal System can be used to connect the Po¬laris Spinal System to the Altius Spinal System, the Lineum OCT Spine 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 indi¬cations for use for each system