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Zimmer Biomet Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries

Tuesday, March 26, 2019

Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® ONE Spine System for robotically assisted minimally invasive and complex spine surgeries, strengthening the Company's comprehensive ROSA® ONE Brain and ROSA® Knee portfolio.

ROSA ONE Spine combines robotics and navigation while delivering a unique real-time patient 'dynamic tracking' capability. The platform features 3D intraoperative planning software in addition to a navigation suite of technologies designed to improve implant as well as 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."