In a significant leap forward for orthopedic and spine technology, SurGenTec, a leading medical device company, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative B-MAN Bone Marrow Aspirate Kit. This clearance marks a pivotal moment in the evolution of bone marrow aspiration, offering a centrifuge-free solution designed to enhance cell viability and reduce impurities.

The B-MAN Kit is engineered with an integrated diamond-tip trocar and CELLect filtration technology, which together maximize marrow contact by up to three times compared to conventional methods. This advanced system efficiently reduces the presence of bone spicules and peripheral blood contamination, thereby optimizing the quality of the aspirate. By eliminating the need for centrifugation—a common step in traditional bone marrow aspiration that can compromise cell health—the B-MAN Kit streamlines the procedure, making it more efficient and less invasive.

“Adding this unique device to our product portfolio aligns with our mission to develop minimally invasive solutions that prioritize patient outcomes,” said Travis Greenhalgh, CEO of SurGenTec. “The B-MAN Kit preserves the native structure of cells and simplifies the extraction process, ultimately providing physicians with a superior autologous option for patient treatment.”

The FDA’s clearance of the B-MAN Kit comes at a time when regenerative medicine is rapidly advancing. The ability to use a patient’s own cells in surgical applications such as orthopedic procedures and spinal interventions significantly lowers the risk of disease transmission, which is a key concern when using products derived from allografts or donors. The B-MAN Kit’s innovative approach not only enhances patient safety but also supports the growing demand for regenerative therapies in clinical settings.

This latest approval follows SurGenTec’s earlier success with the OsteoFlo HydroPutty synthetic bone graft, which also received FDA clearance. The HydroPutty, known for its ease of use and optimized bone growth properties, exemplifies the company’s commitment to developing cutting-edge products for the medical field.

SurGenTec, headquartered in Boca Raton, Florida, is privately owned and continues to make significant strides in the medical device industry. The company has established numerous national Group Purchasing Organization (GPO) agreements and is expanding its reach into international markets. Looking ahead, SurGenTec plans to further diversify its portfolio with new product releases slated for late 2024 and into 2025, reinforcing its position as a leader in orthopedic and spine technology.

This FDA clearance underscores SurGenTec’s ongoing dedication to innovation and patient safety, setting a new standard in bone marrow aspiration technology.

  B-MAN Bone Marrow Aspirate Kit, Bone Marrow Aspiration, FDA clearance, Orthopedic Technology, Regenerative Medicine, Spine Technology, SurGenTec