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FDA Clears SurGenTec®'s OsteoFlo® HydroPutty™: A Hydrophilic Synthetic Bone Graft

Friday, March 08, 2024

SurGenTec, a leading medical device company specializing in orthopedic and spine technologies, is pleased to announce the successful implantations and receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative OsteoFlo HydroPutty Synthetic Bone Graft. This marks a significant advancement in bone graft technology, featuring a proprietary blend of hydrophilic carriers designed to absorb fluids like bone marrow aspirate, blood, or saline. The unique formulation transforms into a putty, offering excellent handling characteristics and an optimized resorption profile for bone growth.

Travis Greenhalgh, Founder and CEO of SurGenTec, expressed his enthusiasm for this milestone: "We're excited to introduce OsteoFlo HydroPutty to our product lineup. Its hydrophilic bonds enable growth factor attachment and provide an ideal structure for bone growth. This underscores our commitment to developing innovative solutions for physicians and patients."

OsteoFlo HydroPutty is provided in a sterile vial as a dry formulation, along with a mixing spatula. Upon fluid addition, the hydrophilic bonds quickly absorb the fluid, creating a putty with superior handling. This versatile product can fill voids, resist irrigation, and be delivered seamlessly through the Graftgun bone graft delivery system.

Offering a synthetic bone graft option, OsteoFlo HydroPutty reduces risks associated with human tissue, including disease transmission and storage issues. SurGenTec's focus on cutting-edge technology empowers healthcare providers to deliver optimal care.

Pre-clinical studies have demonstrated excellent bone growth and integration, showcasing SurGenTec's commitment to improving fusion outcomes through its synthetic biologic product development pipeline.


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