NEW YORK, July 29, 2026 -(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®.
VB Spine Receives FDA Clearances of Expanded Indications for Vitoss® Bone Graft Substitute and Interbody Cage Portfolio
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VB Spine LLCFDA 510(k) clearancesVitoss Bone Graft Substituteinterbody cageposterolateral spine
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.
Contacts
For media inquiries only:
spinecommunications@vbspineco.com
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
VB Spine secured two FDA 510(k) clearances, significantly expanding the market indications for its Vitoss Bone Graft Substitute and interbody cage portfolio. This strategic move broadens their biologics offerings for anterior column, pediatric, and tumor-related spine cases, providing an off-the-shelf alternative to autograft. This enhances their competitive position and aligns with their investment in a comprehensive spine care portfolio.
- The expanded indications for Vitoss and interbody cages target new market segments, including anterior column, pediatric, and tumor-related spine procedures.
- This clearance strengthens VB Spine's portfolio, offering an off-the-shelf solution that reduces surgical complexity and patient discomfort compared to autograft.
PhD Lens: Clinical and outcomes impact
VB Spine obtained FDA 510(k) clearances for its Vitoss Bone Graft Substitute and interbody cages, expanding indications for intervertebral disc space use with cages, anterior column, pediatric, and tumor-related spine cases. Vitoss, a synthetic bone graft, now offers an off-the-shelf alternative to autograft, potentially reducing donor site morbidity and operative time in complex spinal fusion procedures.
- Vitoss, a synthetic bone graft substitute, is now cleared for use in the intervertebral disc space with interbody cages and in the anterior column of the spine.
- Expanded indications include pediatric and tumor-related spinal fusion cases, offering a synthetic alternative to autograft, which is notable for these patient populations.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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