Warsaw, Ind.-based Zimmer Biomet Holdings, Inc. announces that the U.S. FDA has granted 510(k) clearance to the ROSA® Hip system for robotically assisted direct anterior total hip replacement. ROSA Hip is the newest addition to ZBEdge, Zimmer Biomet’s suite of integrated digital and robotic technologies engineered to deliver data-powered clinical insights throughout the patient journey.
“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,” says 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.”
Designed to adapt to a surgeon’s existing workflow, ROSA Hip aims to assist direct anterior surgeons with preparation, positioning, and component impaction, while intra-operatively quantifying cup orientation, leg length, and offset. Intra-operative data collected by ROSA Hip is combined with pre- and post-operative data collected by mymobility® with Apple Watch, a proprietary remote care management platform, and it is consolidated and analyzed by OrthoIntel Orthopedic Intelligence Platform, which is designed to uncover new clinical insights throughout the episode of care and help surgeons and care teams make informed decisions and optimize patient care.
ROSA Hip is designed for compatibility with multiple implant systems, including the Avenir Complete Hip System. Together with the G7 Acetabular System—a comprehensive offering of stems, shells, and liners—the Avenir Complete Hip System aims to deliver greater operative flexibility and surgical excellence to help surgeons address the distinct needs of each patient.
“ROSA Hip will allow surgeons to retain complete control over case planning and execution, while providing real-time data and visualization tools,” adds Atul Kamath, MD, director, Center for Hip Preservation at the Cleveland Clinic and a ROSA Hip developer surgeon. “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.”