Foundation Surgical was granted FDA 510(k) clearance to market its Vertiwedge Intraosseous Device. This novel, motion-sparing partial vertebral body replacement device along with its Vertebral Body Osteotomy (VBO) procedure is designed for use in lateral and motion-sparing spinal procedures.
Vertiwedge is the first intraosseous device designed to facilitate and maintain vertebral body correction of partially collapsed vertebrae via the groundbreaking VBO procedure. This novel single-position, motion-sparing technique allows for effective treatment through a conventional lateral or oblique lateral approach and facilitates indirect decompression of the nerve roots while preserving the natural motion of the disc and facet joints without the need for intervertebral fusion.
“With the FDA clearance of the Vertiwedge and the launch of the VBO procedure, we are ushering in a new era of spine surgery,” said Dr. Randal Betz, founder and CEO of Foundation Surgical. “Our approach allows for the treatment of degenerative conditions while preserving the spine’s natural motion, a significant step forward in patient care.”
The Vertiwedge and VBO stand alongside Foundation Surgical’s earlier innovation, the single-position lateral LLIF180 procedure, which debuted with the FDA clearance of the Interwedge Standalone Lateral Interbody Fusion Device.
Foundation Surgical was granted FDA 510(k) clearance to market its Vertiwedge Intraosseous Device. This novel, motion-sparing partial vertebral body replacement device along with its Vertebral Body Osteotomy (VBO) procedure is designed for use in lateral and motion-sparing spinal procedures.
Vertiwedge is the first intraosseous device designed...
Foundation Surgical was granted FDA 510(k) clearance to market its Vertiwedge Intraosseous Device. This novel, motion-sparing partial vertebral body replacement device along with its Vertebral Body Osteotomy (VBO) procedure is designed for use in lateral and motion-sparing spinal procedures.
Vertiwedge is the first intraosseous device designed to facilitate and maintain vertebral body correction of partially collapsed vertebrae via the groundbreaking VBO procedure. This novel single-position, motion-sparing technique allows for effective treatment through a conventional lateral or oblique lateral approach and facilitates indirect decompression of the nerve roots while preserving the natural motion of the disc and facet joints without the need for intervertebral fusion.
“With the FDA clearance of the Vertiwedge and the launch of the VBO procedure, we are ushering in a new era of spine surgery,” said Dr. Randal Betz, founder and CEO of Foundation Surgical. “Our approach allows for the treatment of degenerative conditions while preserving the spine’s natural motion, a significant step forward in patient care.”
The Vertiwedge and VBO stand alongside Foundation Surgical’s earlier innovation, the single-position lateral LLIF180 procedure, which debuted with the FDA clearance of the Interwedge Standalone Lateral Interbody Fusion Device.
Copy to clipboard 
