FDA Approves Clinical Trial for PEEK-OPTIMA Knee Implant
• The FDA has granted Investigational Device Exemption (IDE) approval for the Freedom® Total Knee System with Invibio PEEK-OPTIMA™ Femoral Component.
• A study involving 120 patients across US clinical sites will compare the PEEK-OPTIMA™ component against traditional metal components in total knee arthroplasty.
• This US study builds upon ongoing clinical trials in Belgium, India, and Italy, which have shown promising results since the first implant in 2021.
• Regulatory submission in India is expected imminently, potentially leading to commercial availability of the PEEK Knee in 2025.
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