Maxx Orthopedics, Inc. (Norristown, PA) and Invibio Biomaterial Solutions™ (Invibio Ltd, part of Victrex plc, Lancashire, UK), today announce that the first-ever U.S. cases using the metal-free PEEK-OPTIMA™ femoral component have been successfully performed as part of a staged Investigational Device Exemption (IDE) clinical study. These landmark procedures, utilizing the Freedom® Total Knee System with Invibio’s advanced PEEK-OPTIMA technology, mark a significant step forward in the evolution of knee replacement materials and implant innovation.
Dr. Andrew Palmisano, a fellowship trained orthopedic hip and knee specialist with Ascentist Healthcare in Kansas City, KS, has performed the first US cases with Invibio’s PEEK-OPTIMA femoral component on May 28, 2025. “I am excited about this technology and it’s exciting to be part of the first cases. I believe this is going to be the way of the future for total knee replacements,” said Dr. Palmisano.
Dr. Siraj Sayeed, board certified, fellowship trained total joint specialist at South Texas Bone & Joint in San Antonio, TX, recently performed his first case with Invibio’s PEEK-OPTIMA femoral component and the Freedom Titan™ tibial baseplate- TiNbN ceramic coated tibial component.
“This is an enormous achievement, and it’s incredibly satisfying to reach another milestone in our partnership with Invibio. We look forward to more cases across select US sites now that the IDE study is officially underway and sharing these results with the orthopedic community in the near future,” said Ashesh Shah, CEO of Maxx Orthopedics.
The PEEK-OPTIMA femoral component is based on Maxx Orthopedics’ Freedom Total Knee System which features a high-flexion, bone-conserving design. The US IDE study compares the Freedom Total Knee System using the PEEK-OPTIMA femoral component to a controlled registry of the same system using traditional metal femoral components.
PEEK-OPTIMA, manufactured by Invibio, is a high-performance biomaterial polymer that delivers performance characteristics such as modulus and flexural strength close to that of cortical bone, contributing to bone density preservation, and features radiolucent material properties that allows artifact-free imaging both during and after implantation.
Invibio is the medical division of Victrex plc. Jakob Sigurdsson, Victrex CEO said “Invibio Biomaterial Solutions and Maxx Orthopedics are dedicated to advancing medical innovation and elevating patient care. Our partnership around the PEEK-OPTIMA femoral knee component has taken another step towards delivering innovation that truly changes large joint orthopedics.”
The PEEK-OPTIMA™ femoral component for primary TKA is not approved for sale in the United States or internationally.
About Maxx Orthopedics, Inc.
Maxx Orthopedics, Inc. is the manufacturer of the Freedom Knee System, Libertas® Total Hip System, and Quick Recovery Solutions® (QRS). We develop and market innovative orthopedic medical devices with a focus on providing state-of-the-art implants and related solutions designed to best restore patient mobility, while accommodating patient lifestyle, anatomical and economic needs. Find out more at www.maxxortho.com/ and follow us on LinkedIn, X, Instagram, and Facebook.
About Invibio Biomaterial Solutions
Invibio, part of the Victrex plc group of companies, is a global leader in providing high-performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA polymers are used in approximately 15 million implanted devices worldwide. Learn more at www.invibio.com