Xtant Medical said today its X-Spine Systems subsidiary won FDA 510(k) clearance for its Xspan laminoplasty fixation system designed for use in the lower cervical and upper thoracic spine.
Spinal laminoplasty is a surgical procedure designed to remove pressure from the spinal cord through the restructuring of the lamina through a window or opening to allow the spinal canal to increase in size without losing stability or movement.
“We are very pleased to have received clearance for Xspan. This system will allow Xtant Medical to further differentiate itself from the competition and will better serve the growing needs of our surgeon partners,” CSO & exec veep Dr. David Kirschman said in prepared remarks.
Xtant Medical said its Xspan will be available to a “limited number of key surgeons” in the 2nd fiscal quarter of 2016 with a larger general release to follow later in 2016. The company said the worldwide market for laminoplasty is estimated to be $110 million “and growing”.
Earlier this month Xtant Medical said it won CE Mark approval in the European Union for its Aranax cervical plating system and and Irix-A stand alone anterior lumbar fusion device.
The company’s Aranax cervical plating system is distributed as a pre-sterilized, ready-to-use implant. The Irix-A stand alone anterior lumbar fusion device consists of an integrated titanium ring in a PEEK shell.