Zimmer Biomet Receives FDA Breakthrough Device Designation for First-of-Its-Kind Iodine-Treated Total Hip Replacement System

Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s first-to-world iodine-treated total hip replacement system — marking the first time in Zimmer Biomet’s history that one of its products has achieved this distinction.

The innovative system incorporates Iodine Technology, a controlled-release iodine surface treatment integrated into the iTaperloc® Complete and iG7™ Hip System, designed to address one of the most significant challenges in joint replacement surgery — infection risk in patients undergoing total hip arthroplasty.

This same system recently received approval from the Japan Pharmaceutical and Medical Devices Agency (PMDA) in September, making it the world’s first approved orthopedic implant utilizing Iodine Technology. In Japan, the device is indicated for inhibiting bacterial adhesion on implant surfaces, offering a novel approach to reducing the incidence of Periprosthetic Joint Infections (PJIs) — a serious complication affecting 1% to 2% of primary total joint arthroplasty (TJA) procedures. PJIs carry significant clinical consequences, with five-year mortality rates nearing those observed in breast cancer (11%), and far exceeding those of prostate cancer (1%).

“The Breakthrough Device Designation from the FDA underscores the need for innovations to reduce complications that can happen with joint replacement procedures and highlights Zimmer Biomet's commitment to advancing technologies that improve patient outcomes and enhance the overall success of musculoskeletal health interventions,” said Ivan Tornos, Chairman, President and CEO. “We look forward to working closely with the agency to bring this first-to-world innovation to patients in the United States.”

The iTaperloc® Complete and iG7™ Hip System combines the proven clinical heritage of the Taperloc Complete Hip System with the efficiency and performance of the G7 Acetabular System, now enhanced through Iodine Technology. Iodine, a biocompatible and essential nutrient, is well-known for its antimicrobial properties and does not contribute to antibiotic resistance, making it a safe and effective addition to implant design.

The FDA Breakthrough Devices Program enables manufacturers to engage closely with regulatory experts throughout the review process, ensuring timely feedback and a prioritized evaluation of novel medical devices. This designation reinforces Zimmer Biomet’s leadership in advancing orthopedic innovation and improving outcomes for patients undergoing joint replacement surgery.

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