Zimmer Biomet earned the FDA’s Breakthrough Device Designation for its iodine-treated total hip replacement system, according to an Oct. 28 news release.
The iodine technology uses a controlled-release surface treatment into the iTaperloc complete and iG7 hip system to address challenges in patients with higher infection risks. The system already has regulatory approval in Japan.
Breakthrough designation allows Zimmer Biomet to work closer with the FDA during the regulatory review process and provides a prioritized review of submissions.
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
