SurGenTec receives FDA clearance for OsteoFlo HydroPutty

SurGenTec announced the first implantations and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OsteoFlo HydroPutty Synthetic Bone Graft.

OsteoFlo HydroPutty represents a significant advancement in bone graft technology, featuring a combination of proprietary hydrophilic carriers designed to absorb fluids such as bone marrow aspirate, blood or saline. This innovative formulation turns to a putty and offers superior handling characteristics with a resorption profile optimized for bone growth.

Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec, expressed enthusiasm about this milestone achievement: “We are thrilled to add OsteoFlo HydroPutty to our portfolio. Its unique hydrophilic bonds enable the attachment of growth factors and provide an ideal scaffolding for bone growth. This product underscores our commitment to developing next-generation solutions for physicians and patients.”

OsteoFlo HydroPutty is supplied in a sterile vial as a dry formulation, accompanied by a mixing spatula. Upon the addition of fluid, the hydrophilic bonds swiftly absorb the desired fluid to form a putty with superior handling characteristics. This versatile product can be packed into voids, resists irrigation, and may even be delivered seamlessly through the Graftgun® bone graft delivery system.

Dr Ashish Patel, MD, Chairman of Spine Surgery at Duly Health and Care, lauded OsteoFlo HydroPutty for its remarkable handling characteristics. “OsteoFlo HydroPutty, with its ability to absorb autologous blood products and its ease of use, fills a critical gap in the realm of synthetic bone grafts. Its unique capability to blend with allograft and flow through small apertures makes it extremely useful when performing both open and minimally invasive surgical procedures.”

Echoing Dr Patel’s sentiments, Dr Tim O’Connor, M.D., Neurosurgeon and Director of Minimally Invasive and Robotic Spine Surgery at Baptist Health, emphasized the product’s versatility and simplicity. “OsteoFlo HydroPutty provides a transformative solution that incorporates growth factors like Bone Marrow Aspirate to enhance fusion opportunity. Most synthetic putties are hydrophobic and repel fluid. HydroPutty differentiates itself by allowing me to deliver next generation hydrophilic bone graft to maximize fusion in minimally invasive surgery.”

OsteoFlo HydroPutty provides physicians with a fully synthetic bone graft option, minimizing the risks associated with human tissue. By offering cutting-edge technology while alleviating concerns such as disease transmission and storage issues, SurGenTec is empowering healthcare providers to deliver optimal care to their patients. Short-term and long-term pre-clinical studies showed excellent bone growth and integration at all time points.
MB Bureau