Zimmer Biomet (NYSE:ZBH) today announced that it received FDA 510(k) clearance for its Rosa Hip system for robotically-assisted surgery.
Warsaw, Ind.-based Zimmer Biomet designed the Rosa Hip personalized robotic system for direct anterior total hip replacement. It is the company’s fourth robotic system and adds to its Rosa robotic portfolio of orthopedic devices, which includes Rosa Knee, Rosa Partial Knee and Rosa One.
“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 platforms,” chief operating officer Ivan Tornos said in a news release. “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 designed to assist direct anterior surgeons with preparation, positioning and component impaction while also intraoperatively quantifying cup orientation, leg length and offset.
Zimmer Biomet’s Rosa Hip system is compatible with a number of implant systems, including the Avenir Complete hip system. It uses fluoroscopy and provides robotic assistance to guide accurate acetabular component orientation and intra-operative assessment of leg length and offset.
“Rosa Hip will allow surgeons to retain complete control over case planning and execution while providing real-time data and visualization tools,” Atul Kamath, director for the Center for Hip Preservation at the Cleveland Clinic, said. “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.”
Surgeons can use the company’s pre-operative planner One Planner Hip with the Rosa Hip system. One Planner has a spinopelvic mobility assessment tool for both a sitting and standing lateral X-ray and an auto-plan function that allows surgeons to create a pre-operative plan within five minutes.