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

Zimmer Biomet (ZBH) received FDA 510(k) clearance to market the ROSA® ONE Spine System for robotically-assisted minimally invasive and complex spine surgeries. The company now has 510(k) clearance for brain, spine and knee offerings on one robotic platform. 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 a navigation suite of technologies to support implant and instrument placement accuracy and predictability. The ROSA Knee application, which received FDA clearance in January 2019, will enter limited launch within 1H19. (Zimmer Biomet, Inc., 3/25/19)