The U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for the Freedom® Total Knee System with Invibio PEEK-OPTIMA™ Femoral Component, a collaboration between Maxx Orthopedics, Inc. and Invibio Biomaterial Solutions. This study aims to compare the performance of the Freedom Total Knee System using the PEEK-OPTIMA Femoral Component against a controlled registry using traditional metal femoral components. PEEK-OPTIMA, a high-performance biomaterial polymer, offers bone density preservation and radiolucent properties for clear imaging. The partnership between Maxx Ortho and Invibio focuses on knee performance testing, optimization, and component manufacturing. The approval marks a significant milestone in the development of this innovative technology, which could potentially revolutionize total knee replacement. Maxx Orthopedics and Invibio have conducted extensive pre-clinical testing and safety studies to support this development. The PEEK-OPTIMA™ femoral component is not yet approved for sale in the U.S. or internationally. Maxx Orthopedics and Invibio are dedicated to advancing medical innovation and improving patient care. For more information, visit Maxx Ortho s and Invibio s websites.
Source: orthospinenews.comPublished on 2024-09-17
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