ZimVie Inc. (NASDAQ:ZIMV), a global life sciences leader in the dental and spine markets, today announced it has received FDA clearance for its Vital™ Spinal Fixation System including instruments for use with Brainlab Spine & Trauma Navigation. This follows the execution of the companies’ Development Cooperation Agreement, announced in March 2023, to achieve compatibility between ZimVie’s Vital and Virage® systems and Brainlab Spine & Trauma Navigation, which helps surgeons plan and execute spinal procedures, accurately place pedicle screws, and minimize radiation exposure.
ZimVie plans to co-market Brainlab Spine & Trauma Navigation alongside its Vital and Virage lines, with first Vital sets expected to be launched in the United States in early 2024. Having secured that clearance, the company plans to submit a 510(k) application to the FDA for Virage next year, as well.
“This is a positive milestone for both teams and the first of what we hope will be many FDA clearances for compatibility. The strong collaboration between our organizations resulted in an expedited project timeline,” said Rebecca Whitney, Global President of ZimVie Spine. “We have been focused on expanding our portfolio with enabling technologies to drive greater adoption, and I am excited to see the team advance toward the launch.”
