First-of-its-Kind Iodine Hip Replacement Approved in Japan for Zimmer Biomet

Zimmer Biomet Holdings, Inc. has received approval from Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for the iTaperloc® Complete and iG7™ Hip System. 

This marks the world’s first regulatory approval of orthopaedic implants using Iodine Technology, designed to reduce bacterial adhesion on implant surfaces.

Periprosthetic Joint Infection (PJI) remains one of the main causes of revision surgery following total joint arthroplasty (TJA), affecting an estimated 1–2% of primary procedures. 

PJI can lead to serious health consequences, with mortality rates approaching those seen in breast cancer and significantly higher than those associated with prostate cancer.

The new hip systems incorporate Iodine Technology, developed to prevent bacterial adhesion and biofilm formation during the critical postoperative period. The technology uses a controlled-release iodine layer applied through advanced anodisation and electrophoresis. 

Iodine, a biocompatible element and essential nutrient, is well known for its antiseptic properties and does not contribute to antibiotic resistance.

The iTaperloc Complete and iG7 Hip System build on the established performance of the Taperloc Complete Hip System and the G7 Acetabular System, combining clinical reliability with design efficiency.

Zimmer Biomet stated that the earlier-than-expected PMDA approval enhances its infection management portfolio, which covers prevention, detection, and both primary and revision joint replacement solutions.