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Home » FDA clears ZimVie and Brainlab spinal fixation combo

FDA clears ZimVie and Brainlab spinal fixation combo

December 12, 2023 By Chris Newmarker

This is a ZimVie marketing image of its Vital spinal fixation system.
The Vital spinal fixation system [Image courtesy of ZimVie]
ZimVie (Nasdaq: ZIMV)  announced today that the FDA has cleared the use of its Vital spinal fixation system with Brainlab’s Spine & Trauma Navigation.

The news comes just nine months after the companies announced a partnership in which Brainlab will provide spine imaging, planning, navigation, and robotic-assisted systems for use with ZimVie implants. The goal is to enable surgeons to better plan and execute spinal procedures, accurately place pedicle screws, and minimize radiation exposure.

“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,” Rebecca Whitney, global president of ZimVie Spine, said in a news release. “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.”

Whitney added to MassDevice‘s sister site Medical Design & Outsourcing: “We see this as the first of several steps to deepen that partnership as we move forward.” [Read more from Whitney on the Brainlab partnership — and what’s next for ZimVie Spine — in MDO.]

Partnering with Brainlab has been ZimVie’s answer to competitors such as Medtronic who have robotic surgery systems and digital surgery offerings to complement their spine implants.

The plan is to launch the first Vital and Brainlab sets in early 2024. Next up in 2024, ZimVie will submit for a 510(k) for use of Brainlab software with ZimVie’s Virage OCT spinal fixation system, which uses extreme-angle omnidirectional screws.

Other medtech companies have turned to Brainlab to enhance their technologies. At our DeviceTalks West show in October, Boston Scientific and Brainlab executives described how the companies have partnered to enhance deep brain stimulation technology.

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Health Technology, News Well, Orthopedics, Regulatory/Compliance, Software / IT, Spine, Surgical, Surgical Robotics Tagged With: Brainlab, ZimVie

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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