FDA OKs SurGenTec’s OsteoFlo HydroFiber Bone Graft

SurGenTec has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its OsteoFlo HydroFiber bone graft technology.

OsteoFlo HydroFiber is now recognized as a standalone solution that’s equivalent to autograft for spine surgeries. This includes use in interbody fusion cages, disc spaces, and posterolateral fusions.

The product uses the company’s Web Interlace technology, which suspends particles in its fibers to prevent graft migration, ensure optimal cohesiveness, and promote flowability. It leverages hydrophilic bonds and proprietary fibers that absorb saline, blood, or bone marrow aspirate.

OsteoFlo HydroFiber can be used with the Graftgun, SurGenTec’s flagship delivery device, to backfill interbody cages.

According to the company, it presents an alternative to human tissue, reducing the risks of donor variability, disease transmission, and storage complications related to allografts. Removing the need for autograft harvesting minimizes surgical time and potential for painful recovery.

“This product is set to revolutionize bone graft technology,” said Travis Greenhalgh, CEO and founder of SurGenTec. “OsteoFlo HydroFiber provides a novel, customizable solution for surgeons, tailored to both anatomy and procedure type. Physicians are familiar with the handling characteristics of fiber-based allograft products, and we are proud to introduce a synthetic option designed to accelerate healing without the risk of human allograft tissue.”

The product is expected to launch in early 2025.

In August 2024, the company received FDA clearance for its B-MAN bone marrow aspiration kit. The B-MAN Kit uses a centrifuge-free method to collect high-quality aspirate with minimal contaminants.