Warsaw-based Zimmer Biomet Holdings Inc. (NYSE: ZBH) has received clearance from the U.S. Food and Drug Administration for its ROSA ONE Spine System. The system is used for robotically-assisted, minimally-invasive and complex spine surgeries.
ROSA ONE Spine is a robotic and surgical navigation system that is designed to aid surgeons in performing spine procedures.
"ROSA ONE Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures," said Aure Bruneau, group president of spine, CMF and thoracic and surgery assisting technology for Zimmer Biomet. "We are extremely excited about the addition of ROSA ONE Spine to our already released ROSA ONE Brain and ROSA Knee Systems."
The FDA’s 510(k) clearance means the ROSA ONE Spine system joins Zimmer Biomet’s ROSA One Brain and ROSA Knee systems, both of which received the same clearance in the first quarter.