SurGenTec, a company specialising in orthopaedic and spine technologies, has received the US Food and Drug Administration (FDA) 510(k) clearance for the OsteoFlo HydroFiber bone graft technology.
OsteoFlo HydroFiber has been approved as a stand-alone solution, equivalent to autograft for spine surgeries. It is designed for use in interbody fusion cages, disc spaces, and posterolateral fusions.
According to SurGenTec, OsteoFlo HydroFiber utilises Web Interlace Technology to suspend particles within its fibres for preventing graft migration effectively. This also ensures optimal cohesiveness and flowability.
The product features hydrophilic bonds and proprietary fibres for absorbing saline, blood, or bone marrow aspirate, while creating a strong platform to support the healing process.
OsteoFlo HydroFiber offers a synthetic bone graft option for orthopaedic and spine surgery, potentially improving patient outcomes. Last year, in March, SurGenTec secured FDA clearance for its OsteoFlo HydroPutty Synthetic Bone Graft.
The OsteoFlo HydroFiber technology can be used with SurGenTec’s Graftgun delivery device to backfill interbody cages efficiently. This provides a significant improvement over the traditional funnel method.
According to the Florida-based medical technology firm, OsteoFlo HydroFiber offers an advanced alternative to human tissue, reducing allograft risks like donor variability, disease transmission, and storage issues.
By eliminating the need for autograft harvesting, the technology minimises surgical time and recovery pain, leading to improved patient outcomes.
With OsteoFlo HydroFiber, surgeons can achieve fusions with a stand-alone bone graft, which removes the need for autografts.
SurGenTec CEO and founder Travis Greenhalgh said: “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.”
The bone graft technology is set for official launch in early 2025.
SurGenTec specialises in orthopaedic and neurosurgical products. In August 2024, the medical device firm secured FDA 510(k) clearance for its proprietary B-MAN Bone Marrow Aspirate Kit.
