Foundation Surgical earned FDA 510(k) clearance for its Vertiwedge intraosseous device, according to a Nov. 8 news release shared with Becker's.
Vertiwedge is a motion-sparing partial vertebral body replacement device that pairs with the newly launched Vertebral Body Osteotomy procedure. It is the first device of its kind designed to facilitate and maintain vertebral body correction of partially collapsed vertebrae.
"With the FDA clearance of the Vertiwedge and the launch of the VBO procedure, we are ushering in a new era of spine surgery," Randal Betz, MD, founder and CEO of Foundation Surgical, said in the release. "Our approach allows for the treatment of degenerative conditions while preserving the spine's natural motion, a significant step forward in patient care."