Musculoskeletal healthcare company Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its ROSA Knee System in robotically-assisted total knee replacement procedures.
The new system offers 3D pre-operative planning tools along with real-time, intraoperative data on soft-tissue and bone anatomy.
ROSA Knee is meant to enhance bone cut accuracy and range of motion gap analysis in order to potentially boost flexion and restore natural joint movement.
The robotically-assisted surgical system is designed to deliver continuous data analysis to help surgeons in complex decision-making and facilitate use of computer and software technology for control and movement of surgical instruments.
It leverages Zimmer Biomet X-Atlas imaging protocol, which enables X-ray preoperative imaging to generate a 3D model and plan of patient’s bone anatomy.
In addition, the ROSA Knee system offers intraoperative, real-time mapping of a patient’s anatomy and motion, allowing surgeons to personalise surgeries and improve outcomes.
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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 personalise 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.”
The company’s portfolio includes orthopaedic reconstructive, sports medicine, biologics, extremities, trauma, spine, craniomaxillofacial and thoracic products; dental implants; and associated surgical products.
The partners developed the Zimmer Biomet mymobility app, with the aim of using Apple Watch to improve how patients communicate with their surgical care teams.