FDA clears VB Spine's Vitoss Bone Graft for use with interbody cages

VB Spine LLC announced that the U.S. Food and Drug Administration has granted two 510(k) clearances expanding the indications for its Vitoss Bone Graft Substitute and interbody cage portfolio, the company said.

The clearances allow Vitoss to be used in the intervertebral disc space alongside interbody cages, and separately expand the indications for VB Spine's interbody cages to include use with bone void fillers cleared for intervertebral body fusion procedures, including Vitoss, according to the company.

Vitoss has previously been used as a bone graft in the extremities, pelvis and posterolateral spine. The newly cleared use extends into the anterior column of the spine, including with interbody cages, and adds indications for pediatric patients and tumor-related cases — a combination the company said is not commonly cleared for synthetic bone grafts.

"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."

Surgeons treating anterior column defects have typically relied on autograft — bone harvested from elsewhere in the patient's body — which can add operative time and discomfort at the donor site, the company said. The expanded indication gives surgeons an off-the-shelf option intended to avoid a second surgical site altogether, a consideration that echoes the broader shift among device makers developing interbody cage systems aimed at reducing reliance on autograft harvest.

VB Spine said the clearance is the latest addition to a biologics and technology portfolio the company has built over the past year. That expansion has included the acquisition of Augmedics' xvision Spine System and CT-Fluoro technology, as well as the launch of the Vulcan Spinal System, according to the announcement. The company has continued to build out its portfolio through additional acquisitions aimed at intraoperative visualization and navigation technology.

Together, VB Spine said, the additions reflect the company's ongoing effort to broaden its spine care offerings for surgeons and patients who need more complex treatment options.

The clearance comes amid continued regulatory activity in the spinal biologics and interbody device space, as manufacturers work to expand the clinical settings in which synthetic and biologic materials can be paired with implant hardware. Bone graft substitutes have gained traction industry-wide as an alternative to autograft, particularly for patients where donor-site morbidity, limited graft supply or additional surgical time are significant concerns. Expanding indications to include pediatric and oncology-related cases marks a notable step for synthetic biologics, an area historically more cautious about extending use beyond adult degenerative disc applications given the added complexity of tumor margins and pediatric bone growth.

As device makers continue to seek expanded FDA clearances that pair biologics with hardware platforms, hospitals and ambulatory surgery centers may see a wider range of off-the-shelf options for anterior column reconstruction — potentially reducing dependence on iliac crest and other autograft harvest sites that have long been considered the standard in spinal fusion.