Maxx Orthopedics and Invibio Biomaterial Solutions have received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for application of the Freedom total knee system with Invibio PEEK-OPTIMA femoral component as a staged study.
 
PEEK-OPTIMA, made by Invibio, is a high-performance biomaterial polymer that delivers modulus and flexural strength close to that of cortical bone to contribute to bone density preservation. It also features radiolucent material properties to allow artifact-free imaging during and after implantation.
 
The PEEK-OPTIMA femoral component is based on Maxx Ortho’s Freedom total knee high-flexion, bone-conserving design. Invibio’s partnership with Maxx Ortho involves it in development, knee performance testing and optimization, and knee component manufacturing using the polymer.
 
The IDE study will compare the Freedom knee with PEEK-OPTIMA femoral components to a controlled registry of the same system using traditional femoral components.

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“The approval of the IDE application for the Freedom Total Knee System with PEEK-OPTIMA Femoral Component is a monumental achievement and the culmination of more than a decade of collaboration between Maxx Ortho and Invibio,” said Corey Perine, chief operating officer of Maxx Orthopedics. “It is incredibly satisfying to see this next step in the development of this innovation reaching fruition.”
 
“We believe this technology has the potential to be a game-changer for total knee replacement, so are excited to be able to further assess its benefits through rigorous clinical evaluation, building on the progress so far,” added Jakob Sigurdsson, CEO of Victrex, of which Invibio is the medical division. “We look forward to the study’s progression and remain optimistic about the transformative impact this pioneering device could have on the future of joint replacement”.