Zimmer Lands FDA Clearance for ROSA Hip System

(photo courtesy of Zimmer Biomet)

Warsaw-based Zimmer Biomet Holdings Inc. (NYSE: ZBH) has received clearance from the U.S. Food and Drug Administration for its ROSA Hip System. The medical device manufacturer says the replacement system is the fourth robotic system introduced by the company.

The systems adds to the company’s ROSA Robotics portfolio, which includes the ROSA Knee System, ROSA Partial Knee System and ROSA ONE for neurosurgical and spine procedures. In April, Zimmer received FDA clearance its ROSA Partial Knee System.

“We’re excited to announce the FDA clearance of ROSA Hip, and to now offer one of the most comprehensive orthopedic robotic solutions through a single, multiple application platform,” said Ivan Tornos, chief operating officer at Zimmer Biomet. “As an integrated component of our ZBEdge Connected Intelligence Suite, ROSA Hip advances our vision to translate pre-, intra-and post-operative data into actionable clinical insights to inform personalized care decisions.”

Zimmer says the ROSA Hip system aims to assist direct anterior surgeons with preparation, positioning and component impaction. Data collected by ROSA Hip is combined with pre- and post-operative data collected by mymobility with Apple Watch, and is analyzed by OrthoIntel Orthopedic Intelligence Platform.

“ROSA Hip will allow surgeons to retain complete control over case planning and execution, while providing real-time data and visualization tools,” said Dr. Atul Kamath, director, Center for Hip Preservation at the Cleveland Clinic and a ROSA Hip developer surgeon. “Even surgeons who are new to robotic-assisted surgery can easily tailor ROSA Hip to adapt to their own workflow. The robotic platform provides support during component positioning, cup impaction and other critical steps of an anterior approach total hip replacement. By reducing the intra-operative variability and inconsistency, this new technology has the potential to give surgeons and their patients greater confidence in seeking value in contemporary total hip replacement.”

You can learn more about ROSA Hip by clicking here.