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Zimmer Biomet Receives FDA Clearance for ROSA ONE Spine System

Posted on March 25, 2019 by Medtech[y] Staff

After recently gaining FDA clearance for their brain and knee applications, Zimmer Biomet today announced the 510(k) clearance the the ROSA ONE Spine System. This approval means that Zimmer Biomet is now the first company with 510(k) clearance for Brain, Spine and Knee applications within one platform.

ROSA One Spine features 3D intraoperative planning software on top of their navigation suite which helps surgeons with implant placement and accuracy. These benefits provide a 'dynamic tracking' environment in real-time during surgeries.

ROSA Spine 3D Video

"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 ONE Spine system is integrated on the same platform as the ROSA ONE Brain and the ROSA ONE Knee systems. The integration will be a benefit for hospitals and surgery centers looking to cut costs and reduce equipment by utilizing a multi-use system at their facility.