SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.
OsteoFlo HydroPutty follows the company’s OsteoFlo NanoPutty, which received FDA clearance in 2020. SurGenTec said that, along with clearance, it can report the first implantations of the new graft as well.
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The new bone graft offers what the company calls a “significant advancement” in bone graft technology. It features a combination of proprietary hydrophilic carriers designed to absorb fluids like bone marrow aspirate, blood or saline. This formulation turns to putty and offers superior handling characteristics, plus a resorption profile optimized for bone growth.
SurGenTec supplies OsteoFlo HydroPutty in a sterile vial as a dry formulation, accompanied by a mixing spatula. Upon the addition of fluid, the hydrophilic bonds absorb that fluid to form a putty. Surgeons can pack it into voids, resist irrigation and may even deliver it through the Graftgun bone graft delivery system.
The fully synthetic bone graft minimizes the risks associated with human tissue. SurGenTec said short-term and long-term pre-clinical data showed excellent bone growth and integration.
“We are thrilled to add OsteoFlo HydroPutty to our portfolio,” said Travis Greenhalgh, founder and CEO of SurGenTec. “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.”
