NEW YORK, July 29, 2026
VB Spine LLC announced that the U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances expanding the indications for its Vitoss® Bone Graft Substitute and interbody cage portfolio. The new clearances allow Vitoss® to be used in the intervertebral disc space with interbody cages, while also expanding the indications for VB Spine’s interbody cages to include use with bone void fillers cleared for intervertebral body fusion procedures, including Vitoss®. The expanded labeling provides surgeons with a cleared off-the-shelf bone graft substitute for spinal fusion procedures, including use in pediatric patients and adults with benign bone tumors or bone cysts, significantly broadening treatment options for complex spinal reconstruction cases.
Expanded Indications Broaden Surgical Options for Spine Fusion
The newly cleared indications represent a significant advancement for VB Spine’s biologics portfolio, allowing Vitoss® Bone Graft Substitute to be used in the anterior column of the spine alongside interbody cages. Traditionally, surgeons performing these procedures have relied on autograft bone harvested from the patient, a process that increases operating time and can lead to additional pain and complications at the donor site. With the FDA’s expanded clearance, surgeons now have access to a synthetic, ready-to-use bone graft substitute that eliminates the need for a second surgical site while supporting bone healing during spinal fusion. The expanded indications also include pediatric applications and tumor-related bone defects, making Vitoss one of the few synthetic bone graft substitutes cleared for this combination of clinical uses.
FDA Clearance Strengthens VB Spine’s Growing Technology Portfolio
According to John Viscogliosi, Co-Chief Executive Officer of VB Spine, the FDA clearance reflects the company’s ongoing investment in expanding treatment solutions for spine surgeons and improving patient care. He noted that providing surgeons with more options for managing complex spinal conditions remains central to the company’s strategy. The latest regulatory milestone builds upon a series of recent portfolio expansions, including the acquisition of Augmedics’ xvision Spine System®, CT-Fluoro technology, and the launch of the Vulcan™ Spinal System. Together, these technologies strengthen VB Spine’s position in the rapidly evolving spinal surgery market by combining advanced biologics, navigation technologies, and implant systems designed to improve surgical precision and patient outcomes.
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VB Spine Continues Advancing Innovation in Spine Care
The expanded FDA 510(k) clearances reinforce VB Spine’s commitment to delivering comprehensive solutions for spinal surgery while addressing the growing demand for less invasive and more efficient treatment options. By enabling the use of Vitoss® Bone Graft Substitute with interbody cages, the company offers surgeons greater flexibility during spinal fusion procedures without the added burden of bone harvesting. As one of the largest privately held spine companies globally, VB Spine continues to expand its biologics and medical technology portfolio through innovation and strategic investments. The latest regulatory achievement further supports the company’s mission to improve surgical outcomes and provide physicians with advanced tools for treating patients with complex spinal disorders.
Source: VB Spine press release
