Maxx Orthopedics, in Partnership with Invibio Biomaterial Solutions, Secures US IDE Approval for PEEK-OPTIMA™ Total Knee Arthroplasty Study
The PEEK-OPTIMA femoral component is based on Maxx Orthopedics’ Freedom Total Knee System high-flexion, bone-conserving design. The study will compare the Freedom Total Knee System using the PEEK-OPTIMA Femoral Component to a controlled registry of the same system using traditional metal femoral components.
NORRISTOWN, Pa., Sept. 17, 2024 /PRNewswire-PRWeb/ — Maxx Orthopedics, Inc. (Norristown, PA) and Invibio Biomaterial Solutions™ (Invibio Ltd, part of Victrex plc, Lancashire, UK), today announces that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for application of Freedom® Total Knee System with Invibio PEEK-OPTIMA™ Femoral Component, as a staged study.
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. The PEEK-OPTIMA femoral component is based on Maxx Orthopedics’ Freedom Total Knee System high-flexion, bone-conserving design. As part of the partnership with Maxx Ortho, Invibio is involved in the development, knee performance testing and optimization, and knee component manufacturing using the polymer.
The study will compare the Freedom Total Knee System using the PEEK-OPTIMA Femoral Component to a controlled registry of the same system using traditional metal femoral components.
“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. It is incredibly satisfying to see this next step in the development of this innovation reaching fruition,” said Corey Perine, Chief Operating Officer, of Maxx Orthopedics.
Invibio is the medical division of Victrex plc. Jakob Sigurdsson, Victrex CEO said “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. 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”.
Maxx Ortho and Invibio have prepared for this IDE application, working together to develop a vast array of pre-clinical testing data, supported by safety studies outside the US. This significant development underscores both companies’ dedication to advancing medical innovation and elevating patient care.
For additional information, please visit www.maxxortho.com and www.invibio.com.
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
About Victrex plc
Victrex is an innovative world leader in high performance polymer solutions, focused on the strategic markets of automotive, aerospace, energy & industrial, electronics and medical. Every day, millions of people use products and applications which contain our sustainable materials – from smartphones, aeroplanes and cars to energy production and medical devices. With over 40 years’ experience, we develop world leading solutions in PEEK and PAEK based polymers, semi-finished and finished parts which shape future performance for our customers and our markets, enable environmental and societal benefits, and drive value for our shareholders. Find out more at www.victrex.com
Media contacts:
Maxx Orthopedics, Inc.
Corey Perine
Victrex plc.
Melanie Embery, Head of Marketing Communications membery@victrex.com,
Group media or Investor Relations enquiries
Andrew Hanson, Director of Investor Relations, Corporate Communications and ESG
Media Contact
Corey Perine, Maxx Orthopedics, 1 484-342-0092, info@maxxortho.com, www.maxxortho.com
SOURCE Maxx Orthopedics
