SurGenTec has gained 510(k) clearance for OsteoFlo HydroFiber, a synthetic material for use in spinal surgery, from the US Food and Drug Administration (FDA).
For use in spinal surgery processes including the filling of interbody fusion cages – hollow cylinders used to fuse two vertebrae together in a spinal fusion procedure – disc spaces, and posterolateral fusions, OsteoFlo Hydrofiber uses SurGenTec’s Web Interlace Technology, which suspends particles within its fibres to prevent graft migration and ensure cohesiveness and flowability once a procedure is complete.
Having undergone almost a decade of research and development, with the FDA clearance, the Florida-based company’s material is recognised as a standalone solution equivalent to autografts, in which a patient’s own tissue is used, in spinal surgeries.
By removing the need for autograft harvesting, the company claims OsteoFlo may deliver better patient outcomes by minimising surgical time and the potential for painful recovery post-surgery.
OsteoFlo also provides an alternative to allografts, in which tissue is harvested from another person’s body, thereby mitigating potential risks associated with the process such as donor variability, disease transmission, and storage complications.
SurGenTec founder and CEO Travis Greenhalgh commented: “This product is set to revolutionise bone graft technology.
“OsteoFlo HydroFiber provides a novel, customisable solution for surgeons, tailored to both anatomy and procedure type. Physicians are familiar with the handling characteristics of fibre-based allograft products, and we are proud to introduce a synthetic option designed to accelerate healing without the risk of human allograft tissue.”
SurGenTec plans to officially launch OsteoFlo HydroFiber in early 2025.
Dr Micah Smith of Ortho NorthEast commented: “This innovative solution marks a significant advancement in the field, demonstrating performance that matches or exceeds autografts in both posterolateral gutters and interbody spaces.
“The fibre component enhances flowability and cohesion, preventing migration and ensuring the graft remains precisely where it is placed.”
According to GlobalData analysis, the global spinal surgery market is expected to grow at a CAGR of 3.1% over the next decade, reaching a valuation of around $16.1bn by 2033.
In 2024, SurGenTec received FDA clearance for the B-MAN Bone Marrow Aspirate Kit, a medical device designed to aid in the more efficient extraction of bone marrow for use in surgical procedures.
