Zimmer Biomet Receives FDA Breakthrough Device Designation for Iodine-Treated Hip Replacement System

Zimmer Biomet has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its iodine-treated total hip replacement system, the first device of its kind in the United States. The designation follows recent approval from Japan’s PMDA, which cleared the technology in September as the world’s first orthopedic implant to incorporate iodine-based surface treatment.

The company’s system integrates a controlled-release iodine coating into the iTaperloc Complete and iG7 Hip System, combining established implant platforms with technology designed to reduce bacterial adhesion on implant surfaces. The approach is intended to address periprosthetic joint infections, a rare but serious complication affecting an estimated 1–2 percent of primary total joint arthroplasty procedures.

“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,” said Ivan Tornos, Chairman, President and CEO.

Iodine is a biocompatible antimicrobial commonly used in medicine and is not associated with antibiotic resistance. The Breakthrough designation enables closer engagement with regulators during the review process, which may streamline U.S. market access once a formal submission is filed.