FDA Clears Hydrophilic Synthetic Bone Graft Putty

This product can be packed into voids, resists irrigation, and can be delivered through the Graftgun.

Osteo Flo Hydro Putty Picture 4

SurGenTec, a medical device company specializing in orthopedic and spine technologies, 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 an 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 formulation turns to a putty and offers superior handling characteristics with a resorption profile optimized for bone growth.

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 absorb the desired fluid to form a putty. This product can be packed into voids, resists irrigation, and may even be delivered through the Graftgun bone graft delivery system.

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.

SurGenTec, headquartered in Boca Raton, Florida, is dedicated to developing and manufacturing innovative products for the orthopedic and neurosurgical spine fields. With a strong presence both domestically and internationally, SurGenTec is committed to optimizing fusion through its pipeline of synthetic biologic product development.

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