510(k) clearance for the Avance MIS pedicle screw system

The Avance medical device system will be in limited market release in the Q2 & Q3 of 2014, and is planned for full launch in the Q4 of 2014.

April 14, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations Materials People/Facilities

Raleigh, N.C. – Baxano Surgical Inc., a medical device company focused on designing, developing, and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, has received U.S. Food and Drug Administration (FDA) 510(k) clearance (k133743) of its Avance MIS pedicle screw system, which may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies. The innovative design of Avance provides a quick and easy-to-use, percutaneous pedicle screw system that addresses single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma. The Avance system will be in limited market release in the second and third quarter of 2014 and is planned for full launch in the fourth quarter of 2014.

"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," stated Ken Reali, president and CEO of Baxano Surgical. "Avance will significantly enhance our ability to meet customer needs and gain a stronger foothold in the MIS fusion market."

"The Avance system provides a truly percutaneous approach designed to minimize tissue trauma and eliminate additional rod insertion incision," stated spine surgeon Sameer Mathur, M.D. "The scientific engineering used to design Avance lowers the construct's overall profile, increases intraoperative flexibility and enhances lock down security," stated Nael Shanti, M.D. Drs. Mathur and Shanti are surgeon designers of the Avance system.

About the Avance MIS pedicle screw system
The Avance MIS pedicle screw system is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. The Avance system accommodates single level degenerative procedures as well as multi-level, complex pathologies from T1 to S1.

Source: Baxano Surgical Inc.