Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) 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. This marks the first time in Zimmer Biomet’s history that one of its products has received this designation.
The designation recognizes the potential of Zimmer Biomet’s iodine technology, which integrates a controlled-release iodine surface treatment into the iTaperloc® Complete and iG7™ Hip System. The innovation aims to help reduce infection risks in joint replacement procedures, particularly for patients at higher susceptibility.
The system was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in September 2025, making it the world’s first orthopedic implant with iodine surface treatment. In Japan, it is indicated for inhibiting bacterial adhesion on the implant surface, addressing periprosthetic joint infections (PJI) — a serious complication that affects an estimated 1–2% of primary total joint arthroplasties (TJA). PJIs are associated with significant morbidity and mortality, with five-year death rates approaching those seen in breast cancer (11%) and exceeding those in prostate cancer (1%).
“The Breakthrough Device Designation from the FDA underscores the need for innovations that reduce complications in joint replacement procedures,” said Ivan Tornos, Chairman, President and CEO of Zimmer Biomet. “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 builds on the clinical heritage of the Taperloc Complete Hip System and the design efficiency of the G7 Acetabular System, integrating iodine’s antimicrobial properties into proven implant platforms. Iodine is a biocompatible, essential nutrient widely used in medicine as an antiseptic and does not promote antibiotic resistance.
The FDA’s Breakthrough Devices Program facilitates close collaboration between device manufacturers and the agency during regulatory review, offering priority review and accelerated feedback to help advance technologies that address unmet medical needs.
Zimmer Biomet is a global medical technology company with a portfolio spanning orthopedic implants, digital health, and robotic surgical solutions. With operations in over 25 countries and product sales in more than 100, the company focuses on enhancing mobility and improving musculoskeletal health.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!