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BD - Earth day 2024

SurGenTec® Receives FDA Clearance for Breakthrough OsteoFlo® HydroPutty™

SurGenTec, a leading innovator in medical devices for orthopedic and spine applications, is proud to announce the successful implantations and receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking OsteoFlo HydroPutty Synthetic Bone Graft.

This achievement marks a significant advancement in bone graft technology, as OsteoFlo HydroPutty utilizes a unique blend of hydrophilic carriers to absorb fluids such as bone marrow aspirate, blood, or saline. This proprietary formulation transforms into a putty with excellent handling properties and a resorption profile optimized for bone growth. Supplied in a sterile vial as a dry formulation, OsteoFlo HydroPutty can be easily mixed using the accompanying spatula.

Once fluid is added, the hydrophilic bonds rapidly absorb it, resulting in a putty with superior handling characteristics. According to a representative from SurGenTec, OsteoFlo HydroPutty fills a crucial gap in the market for synthetic bone grafts. Its ability to absorb autologous blood products and blend with allograft makes it extremely versatile for various surgical procedures, including minimally invasive approaches.

OsteoFlo HydroPutty offers a transformative solution by incorporating growth factors like Bone Marrow Aspirate to enhance fusion opportunities. Unlike most synthetic putties that repel fluids, HydroPutty's hydrophilic nature maximizes fusion potential, particularly in minimally invasive surgeries.

By providing physicians with a fully synthetic bone graft option, SurGenTec aims to minimize the risks associated with human tissue while delivering cutting-edge technology. This empowers healthcare providers to offer optimal care to their patients Pre-clinical studies, both short-term and long-term, have demonstrated excellent bone growth and integration at all stages, further validating the efficacy of OsteoFlo HydroPutty.

Source: https://www.businesswire.com/news/home/20240307048621/en/

 

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