Zimmer Biomet Holdings, Inc. has announced that the U.S. Food and Drug Administration (FDA) granted ‘Breakthrough Device Designation’ for its new iodine-treated total hip replacement system, the first of its kind in the world and the company’s first device to receive this honor. The recognition highlights growing global efforts to make orthopedic implants safer by reducing infections that can occur after surgery.
Zimmer Biomet’s system uses Iodine Technology, built into the iTaperloc® Complete and iG7™ Hip Systems. The implant’s surface is treated with a controlled-release iodine coating that slowly releases iodine over time. This iodine layer helps prevent bacteria from sticking to the implant, one of the key causes of Periprosthetic Joint Infections (PJIs) after joint replacement surgery.
PJIs are rare but serious, affecting around 1–2% of patients undergoing hip or knee replacements. They can lead to severe pain, the need for additional surgeries and even life-threatening complications. Studies show that PJI-related death rates can be similar to those seen in some cancers, including breast cancer.
In September 2025, Japan’s Pharmaceutical and Medical Devices Agency (PMDA) approved this same system making it the first orthopedic implant in the world to use iodine surface technology. The approval in Japan recognizes its potential to stop bacteria from attaching to the implant and starting infections.
Iodine is a biocompatible element, safe for the body and already well-known for its antiseptic properties. Unlike antibiotics, it does not create resistance, making it ideal for long-term infection control. The iodine coating on the implant slowly releases small, safe amounts of iodine that create an antibacterial surface without affecting the bone or surrounding tissue.
The new iodine-treated hip system combines the proven reliability of Zimmer Biomet’s traditional hip replacement designs with modern infection-prevention technology. It represents a major step forward in making surgeries safer and recovery outcomes more successful, especially for patients at higher risk of infection.
“This Breakthrough Device Designation emphasizes the importance of innovation in preventing surgical complications,” said Ivan Tornos, Chairman, President and CEO of Zimmer Biomet. “We’re proud to work with the FDA to bring this unique technology to U.S. patients.”
Through the FDA’s Breakthrough Devices Program, Zimmer Biomet will receive faster regulatory guidance, helping speed up the path to market for this infection-resistant implant. The technology could also set a new global standard for next-generation orthopedic devices designed to fight bacteria from the very start.
Disclaimer: This article is for informational and educational purposes only. It summarizes publicly available medical and regulatory information and should not be taken as medical advice. For personal medical concerns, please consult a qualified healthcare professional.
