VB Spine Wins Expanded FDA Nods for Vitoss Bone Graft, Interbodies

VB Spine has received two U.S. Food and Drug Administration (FDA) 510(k) clearances that expand the indications for its Vitoss bone graft substitute and interbody cage portfolio.

The clearances allow Vitoss’ use in the intervertebral disc space with interbody cages. They also expand the indication for the company’s interbody cages to include use with bone void fillers cleared for use in intervertebral body fusion procedures, which includes Vitoss.

Surgeons treating anterior column defects have traditionally relied on autograft, which requires harvesting bone from another part of the patient’s body and can increase operative time and donor-site discomfort. The expanded indication provides an off-the-shelf alternative that eliminates the need for a second surgical site.

The clearance expands VB Spine’s biologics and technology portfolio, which has grown over the past year through the acquisitions of Augmedics’ xvision Spine System and CT-Fluoro technology and the launch of the Vulcan spinal system.

“This FDA clearance reflects the continued growth of our biologics portfolio and our commitment to broadening our offerings for surgeons and their patients,” said John Viscogliosi, co-CEO of VB Spine, speaking on behalf of his brothers and fellow co-CEOs Anthony and Marc Viscogliosi. “At VB Spine, everything starts with the patient, and giving surgeons more ways to treat their most complex cases is exactly the kind of growth we want to keep investing in.”