New indications give surgeons a cleared option for bone grafting in procedures using interbody cages, including in children and adults with benign bone tumors or cysts
NEW YORK–(BUSINESS WIRE)–VB Spine LLC (“VB Spine”) today announced that the U.S. Food and Drug Administration (FDA) granted two 510(k) clearances that expand the indications for its Vitoss® Bone Graft Substitute and interbody cage portfolio. The clearances allow Vitoss® to be used in the intervertebral disc space with interbody cages and expand the indications for VB Spine’s interbody cages to include use with bone void fillers cleared for use in intervertebral body fusion procedures, including Vitoss®.
Vitoss has long been used as a bone graft in the extremities, pelvis, and posterolateral spine. This new use in the anterior column of the spine includes interbody cages; additional indications include pediatric patients, and tumor-related cases, a combination 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 expanded indication gives surgeons an off-the-shelf option that avoids a second surgical site altogether.
This clearance is the latest addition to a biologics and technology portfolio that VB Spine has built over the past year, including its acquisitions of Augmedics’ xvision Spine System® and CT-Fluoro technology, as well as the launch of the Vulcan™ Spinal System. Together, they reflect VB Spine’s commitment to advancing spine care for the patients who need it most.
Vitoss is a registered trademark of Stryker Corporation or one of its affiliates and is used by VB Spine under license.
Forward-Looking Statements
Certain statements in this release are forward-looking and are based on current expectations, forecasts, and assumptions. Actual results may differ materially due to regulatory, commercial, and operational risks. VB Spine disclaims any obligation to update forward-looking statements except as required by law.
About VB Spine
VB Spine LLC is the largest privately held spine company and among the largest family-owned medical technology companies in the world. With a comprehensive portfolio and a large and growing global distribution network, VB Spine delivers specialized solutions that address critical needs in spine surgery and enhance patient outcomes. Focused on people, partnerships and operational excellence, VB Spine ensures healthcare professionals have access to the tools and resources needed to provide the highest standard of care. VB Spine is owned and led by the Viscogliosi Brothers. For more information on VB Spine, please visit www.vbspineco.com.
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