News | February 12, 2019

Zimmer Biomet Receives FDA Clearance For ROSA One Brain Application

Zimmer Biomet has received U.S. Food and Drug Administration (FDA) clearance for the ROSA One Brain Application, a robotic surgical navigation and positioning system for use in neurosurgical procedures. The ROSA One Brain Application is the next generation of the neurosurgical device from Zimmer Biomet, building upon the previous success of ROSA Brain with enhanced performance and usability. Additionally, the ROSA One platform was designed to be expandable into other specialties, with a Spine Application currently pending clearance. Having a single robot able to perform both brain and spine surgery will significantly advance Zimmer Biomet’s position in the robotic surgical space.

Clearance of the ROSA One Brain Application comes on the heels of another addition to Zimmer Biomet’s robotic portfolio: ROSA Knee, which was cleared in late January 2019 for robotic assisted total knee replacement surgery.

ROSA One Brain Application is a dynamic platform that can be used to assist in minimally invasive neurosurgery procedures, ranging from biopsies and stereo-electro-encephalography (SEEG) to deep brain stimulation and ventricular and transnasal endoscopy. The ROSA Brain portfolio has had a particularly strong impact in the field of epilepsy surgery, where the speed and accuracy of the robot make it well suited for complex procedures where multiple instruments are inserted into the brain. The pending clearance of the ROSA One Spine Application is expected to bring these same robotic advantages to thoracolumbar spine surgery, assisting in the accurate and reproducible placement of surgical instruments in spinal procedures.

Source: Zimmer Biomet