SurGenTec’s OsteoFlo HydroFiber Bone Graft Earns Expanded FDA Nod

SurGenTec has earned an additional U.S. Food and Drug Administration (FDA) 510(k) clearance for its OsteoFlo HydroFiber advanced synthetic bone graft.

The indication expansion includes use as a bone void filler to treat tumors, cysts, trauma, and osteomyelitis. This complements the company’s previous FDA nod for OsteoFlo HydroFiber, which the company said is equivalent to autograft in spine surgery and versatile enough for use at any spinal level, including for posterolateral fusions, disc spaces, or interbody fusion cages.

The technology boasts the company’s Web Interlace technology, which suspends particles in its fibers to prevent graft migration, cohesiveness and flowability. Intricate hydrophilic bonds and proprietary fibers allow wicking of saline, blood, or bone marrow aspirate.

The product’s formulation permits optimal handling and resists migration under irrigation, SurGenTec said. It can be used in surgical settings including spine, orthopedics, and foot/ankle procedures. Additionally, it can be utilized with the GraftGun, the company’s flagship delivery device, to efficiently backfill interbody cages and tight spaces.

The company hopes to reduce the surgical risks usually related to traditional autografts and allografts with OsteoFlo HydroFiber.

“Receiving this FDA clearance for OsteoFlo HydroFiber is a major milestone for SurGenTec,” said Travis Greenhalgh, CEO and founder of SurGenTec. “Our team has worked diligently in product development and testing to extend our capabilities and support more patients undergoing complex surgeries. Treating tumors and osteomyelitis presents significant challenges with limited options available. Our technology offers a powerful, autograft-equivalent solution, providing optimal clinical outcomes without the need for autograft harvesting. This allows physicians to avoid the invasive procedure and risks associated with autograft while still delivering exceptional results, positioning our product as the superior choice over allograft.”

The company also plans to reveal a new international headquarters, set to become operational in Q3 2025.