ROSA Hip is a fluoroscopy-based tool that is designed to adapt to a surgeon's existing workflow
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Zimmer Biomet has secured the US FDA 510(k) clearance for the ROSA Hip System for robotically-assisted direct anterior total hip replacement.
ROSA Hip, which is the company’s fourth robotic system, is an addition to its ROSA Robotics portfolio.
The portfolio consists of the ROSA Knee System for total knee arthroplasty, ROSA Partial Knee System for partial knee arthroplasty and ROSA ONE for neurosurgical and spine procedures.
ROSA Hip is also the latest addition to ZBEdge, which is a suite of integrated digital and robotic technologies offered by Zimmer Biomet to provide transformative data-powered clinical insights.
Zimmer Biomet chief operating officer Ivan Tornos said: “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.
“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.”
ROSA Hip is a fluoroscopy-based tool that is designed to adapt to a surgeon’s existing workflow. It is compatible with multiple implant systems, including the Avenir Complete Hip System, an evolution of the Avenir Hip Implant.
The system is designed to support assist direct anterior surgeons with preparation, positioning and component impaction.
It provides robotic assistance to guide accurate acetabular component orientation as well as intra-operative assessment of leg length and offset.
In addition, ROSA Hip enables surgeons to create a personalised surgical plan through the use of ONE Planner Hip.
The Cleveland Clinic’s Center for Hip Preservation director and a ROSA Hip developer surgeon Atul Kamath said: “ROSA Hip will allow surgeons to retain complete control over case planning and execution, while providing real-time data and visualization tools.
“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.”
In February this year, Zimmer Biomet has announced plans to spin off its spine and dental businesses to create a new independent and publicly traded company.