ZimVie Receives FDA 510(K) Clearance for Breakthrough Collaboration with Brainlab

ZimVie and BrainLab

ZimVie Inc. (Nasdaq: ZIMV) proudly announced the FDA 510(k) clearance for its innovative Vital™ Spinal Fixation System which includes instruments for use with Brainlab Spine and Trauma navigation. This significant achievement is the result of a visionary Development Cooperation Agreement with Brainlab, a collaboration initiated in March 2023 to redefine spinal care.

The core objective of the collaboration between ZimVie and Brainlab was to establish seamless compatibility between ZimVie’s Vital and Virage® systems and Brainlab’s Spine & Trauma Navigation technology. This forward-thinking approach lays the foundation for a new era in surgical precision and safety for spinal procedures.

Co-Marketing ZimVie and Brainlab Spine & Trauma Navigation

The journey of collaboration between ZimVie and Brainlab began with the pursuit of compatibility between Vital and Virage fixation systems and Brainlab’s spine and trauma navigation technologies. Over the months, this partnership has evolved, culminating in the expanded agreement in August to include co-marketing efforts.

ZimVie envisions a synergistic market approach by co-marketing Brainlab Spine & Trauma Navigation alongside its renowned Vital and Virage product lines. The strategic alignment of these innovations promises to elevate the standards of spinal care, offering surgeons advanced tools for meticulous planning and execution.

At the heart of this collaboration is Brainlab’s groundbreaking software, designed to revolutionize the accuracy of device placement in spinal fusion procedures. By optimizing screw placement precision and minimizing the need for verification scans, the software contributes to a substantial reduction in X-ray exposure for both patients and surgical teams.

Future Prospects: 510(k) Application for Virage

Building on the momentum of FDA clearance, ZimVie is gearing up for the much-anticipated launch of Vital sets in the United States, scheduled for early 2024. This introduction signifies a significant leap forward in providing healthcare professionals with state-of-the-art tools for spinal procedures.

With the clearance for Vital secured, ZimVie is now actively preparing to submit a 510(k) application for Virage in the coming year. This application signals the company’s ongoing commitment to innovation and expansion in the field of spinal care.

Looking Ahead: ZimVie and BrainLab

This week’s FDA clearance marks a monumental achievement for the collaboration, unlocking the door to a new era of spinal solutions. ZimVie is poised to make waves in the market, introducing the first Vital Spinal Fixation System sets to the U.S. market early next year. Simultaneously, the company is setting its sights on a 510(k) filing for Virage, reinforcing its commitment to innovation and excellence in spinal care.

As we look forward to the dawn of this transformative collaboration, the horizon of spinal surgery appears brighter than ever, thanks to ZimVie’s dedication to advancing healthcare through pioneering technologies. The combined strengths of ZimVie and Brainlab are set to reshape the landscape of spinal solutions, promising enhanced precision, safety, and outcomes for patients globally.


  • https://investor.zimvie.com/news-releases/news-release-details/zimvie-announces-compatibility-between-its-vitaltm-spinal
  • https://seekingalpha.com/article/4583601-zimvie-inc-zimv-q4-2022-earnings-call-transcript
  • https://www.brainlab.com/surgery-products/overview-spinal-trauma-products/

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