New screw system from Baxano Surgical gets 510(k) clearance 

Baxano Surgical Inc., a medical device company that makes products to treat degenerative conditions of the lumbar spine, has received FDA 510(k) clearance of its Avance MIS Pedicle Screw System. 

The system will have limited market release in the second and third quarters of 2014, and a full release is expected by the fourth quarter of this year. 

“This FDA clearance represents a significant addition to Baxano Surgical’s MIS product portfolio and offers surgeon and hospital customers an additional solution for their lumbar fusion procedures,” Ken Reali, president and CEO of Baxano Surgical, stated in a company press release. “Avance will significantly enhance our ability to meet customer needs and gain a stronger foothold in the MIS fusion market.” 

According to the release, the system is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients. It can be used as an adjunct to fusion for such indications as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor and pseudoarthrosis and failed fusion. 

The design of Avance provides a percutaneous pedicle screw system that addresses single, complex and multilevel spinal pathologies with minimal tissue disruption and trauma, as noted in the press release.  