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Zimmer Biomet Gains FDA Clearance of ROSA ONE Spine System

Zimmer Biomet (ZBH) received FDA 510(k) clearance to market the ROSA® ONE Spine System for robotically-assisted minimally invasive and complex spine surgeries. 

ROSA ONE Spine combines robotics and navigation while delivering real-time patient dynamic tracking that allows the robot to move with the patient. It features 3D intraoperative planning software and navigation to support implant and instrument placement accuracy and predictability.

"ROSA ONE Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures," said Aure Bruneau, Zimmer Biomet's Group President, Spine, CMF and Thoracic and Surgery Assisting Technology. "We are extremely excited about the addition of ROSA ONE Spine to our already released ROSA ONE Brain and ROSA Knee Systems."

The ROSA Knee application, which received FDA clearance and CE Mark approval in 1Q19, is entering limited launch in 1H19.

Analysts at Wells Fargo estimate that the spine application could contribute up to $15MM to Zimmer Biomet sales in 2019. They noted that with this clearance, the company can now offer brain and spine on a single platform. While the knee application remains on a different chassis, the company may integrate knee, spine and brain onto one platform in the future.

The company has an installed base of 100 ROSA systems in the U.S., currently.


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