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.
