SurGenTec has announced 510(k) clearance from the US Food and Drug Administration (FDA) for its OsteoFlo HydroPutty Synthetic Bone Graft.
OsteoFlo HydroPutty is a hydrophilic synthetic bone graft intended to absorb fluids such as bone marrow aspirate, blood or saline.
The product’s proprietary hydrophilic carriers enable it to transform into a putty-like substance, providing surgeons with superior handling characteristics and an optimised resorption profile for bone growth.
SurGenTec founder and CEO Travis Greenhalgh said: “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.”
The OsteoFlo HydroPutty product is presented in a sterile vial as a dry formulation and comes with a mixing spatula.
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When fluid is added, the hydrophilic bonds quickly absorb it, creating a putty that is easy to handle, can be packed into bone voids, resists irrigation and is compatible with SurGenTec’s Graftgun bone graft delivery system.
Duly Health and Care spine surgery chairman Dr Ashish Patel said: “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.”
Pre-clinical studies, both short-term and long-term, have demonstrated ‘excellent bone growth and integration’ at all time points, indicating the potential of OsteoFlo HydroPutty to significantly impact patient care.
In October 2023, SurGenTec’s posterior sacroiliac joint fusion system, TiLink-P, obtained clearance from the FDA.
