Musculoskeletal healthcare firm Zimmer Biomet has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Rosa knee robotically-assisted surgical system.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The FDA approval enables to use the Rosa knee system in robotically-assisted total knee replacement surgeries.
Zimmer’s new system is provided with 3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy to enhance cut accuracy and various motion gap analysis to improve flexion and restoration of natural joint movement.
Rosa knee is part of Zimmer Biomet’s Rosa robotics platform, which also includes Rosa Brain for neurosurgical procedures.
The Rosa knee robotically-assisted surgical system will enable surgeons to better deal with bone resections and evaluate the state of soft tissues to facilitate implant positioning intraoperatively.
The system is said to offer a continuity of data analysis to solve complex decision-making and supports surgeons to use computer and software technology to control and move surgical instruments.
Zimmer also provided Rosa knee system with X-Atlas imaging protocol to offer x-ray based preoperative imaging to create a 3D model and plan of a patient’s bone anatomy. It will also help to form a patient’s anatomy and motion to assist surgeons personalize procedures and improve outcomes.
Zimmer Biomet orthopedics group president Ivan Tornos said: “We are excited for the launch of Rosa Knee, which brings together Zimmer Biomet’s robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients.
“Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes.”
Established in 1927, Zimmer Biomet is engaged in the designing, manufacturing and marketing of orthopedic reconstructive products, sports medicine, biologics, extremities and trauma products.
The company also provides office-based technologies, spine, craniomaxillofacial and thoracic products, dental implants and related surgical products.
Based in Warsaw of Indiana, Zimmer Biomet works with healthcare professionals across the globe to advance the development of products and solutions to treat patients suffering from disorders or injuries to bones, joints and soft tissues.