Zavation has received 510(k) clearance from the US Food and Drug Administration (FDA) to market Normandy VBR System (cervical and thoracolumbar expandable corpectomy cage).
The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy.
The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw.
Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.
The Normandy VBR System is indicated for use in the cervical spine (C2-C7) and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion.
The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.
Jeffrey Johnson (Zavation CEO) stated, “Our research and development team has hit a home run with this new expandable corpectomy device. Not only is it one of the first expandable corpectomy devices cleared for cervical use; but the ease of insertion, ease of expansion, and large graft area sets a new industry standard!”
Source: Company Press Release