{"id":36610,"date":"2025-10-28T12:55:00","date_gmt":"2025-10-28T12:55:00","guid":{"rendered":"https:\/\/g-medtech.com\/news\/?p=36610"},"modified":"2025-10-28T12:55:04","modified_gmt":"2025-10-28T12:55:04","slug":"zimmer-biomet-receives-fda-breakthrough-device-designation-for-iodine-treated-hip-replacement-system","status":"publish","type":"post","link":"https:\/\/g-medtech.com\/news\/zimmer-biomet-receives-fda-breakthrough-device-designation-for-iodine-treated-hip-replacement-system\/","title":{"rendered":"Zimmer Biomet Receives FDA Breakthrough Device Designation for Iodine-Treated Hip Replacement System"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/g-medtech.com\/directory\/listings\/zimmer-biomet\/\" target=\"_blank\" rel=\"noreferrer noopener\">Zimmer Biomet<\/a> 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\u2019s PMDA, which cleared the technology in September as the world\u2019s first orthopedic implant to incorporate iodine-based surface treatment.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The company\u2019s 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\u20132 percent of primary total joint arthroplasty procedures.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cThe 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&#8217;s commitment to advancing technologies that improve patient outcomes,\u201d said Ivan Tornos, Chairman, President and CEO.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Zimmer Biomet has secured FDA Breakthrough Device Designation for its iodine-treated total hip replacement system, following recent approval in Japan and marking the company\u2019s first breakthrough-designated technology.<\/p>\n","protected":false},"author":2,"featured_media":36611,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"colormag_page_layout":"default_layout","footnotes":""},"categories":[7,488,711,25],"tags":[687,138],"class_list":["post-36610","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-americas","category-breaking-news","category-orthopaedics","category-products-technologies","tag-fda","tag-zimmer-biomet"],"_links":{"self":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/36610","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/comments?post=36610"}],"version-history":[{"count":1,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/36610\/revisions"}],"predecessor-version":[{"id":36612,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/36610\/revisions\/36612"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media\/36611"}],"wp:attachment":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media?parent=36610"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/categories?post=36610"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/tags?post=36610"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}