Zimmer Biomet Earns FDA Breakthrough Status for Iodine-Treated Hip Implant

Zimmer Biomet has secured FDA Breakthrough Device Designation for its iodine-treated total hip replacement system, which integrates a controlled-release iodine layer to reduce the risk of post-surgical infections. The system, already approved in Japan, could offer protection for patients at higher infection risk by preventing bacterial biofilm formation on implant surfaces — a complication affecting 1–2% of joint replacement patients and carrying an 11% three-year mortality rate.

The innovation combines anodization and electrophoresis techniques to embed iodine into Zimmer’s Taperloc Complete Hip System, delivering sustained antimicrobial activity. Iodine’s broad antibacterial action, low resistance potential, and human safety profile make it an attractive alternative to antibiotic coatings.

The breakthrough status will enable closer FDA collaboration, expediting development and review. The move follows Zimmer’s earlier challenges introducing anti-infection implant technologies in the U.S., underscoring its renewed focus on infection-resistant orthopedic solutions.

03-11-2025