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The Cortera™ Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera™ Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera™ Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.

The Cortera Spinal Fixation System (Cortera System) is a thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or the sacral spine. The Cortera System consists of screws, rod-to-rod connectors, lateral offset connectors, rods, locking set screws and associated reusable manual surgical instruments for an open or minimally invasive surgical approach. The screws, rod-to-rod connectors, lateral offset connectors, and set screws are manufactured from titanium alloy (Ti6Al4V per ASTM F136). The rods are available in titanium alloy or cobalt chromium alloy (Co-28Cr-6Mo per ASTM F1537). The implants are available in a variety of sizes to accommodate individual patient anatomy and are provided non-sterile. A variety of these implant configurations were previously covered in K221403. The Cortera System rods may be used in connection with Streamline Cross Connectors, cleared by FDA in K192800. The Streamline Cross Connectors accept various rod diameters and are appropriate for use with Cortera System 5.5 mm diameter rod-based systems. These cross connectors will keep their original cleared trade name.