Zimmer Biomet Receives FDA Clearance for ROSA® Shoulder System - the World's First Robotic Assistant for Shoulder Replacement Surgery
Zimmer Biomet Holdings, Inc a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Shoulder System for robotic-assisted shoulder replacement surgery. ROSA Shoulder is the world's first robotic surgery system for shoulder replacement, and the fourth application for the Company's comprehensive ROSA® Robotics portfolio, which includes the ROSA® Knee System for total knee arthroplasty and ROSA® Hip System for total hip replacement.
ROSA Shoulder strengthens Zimmer Biomet's innovative shoulder implant portfolio, which includes the Identity Shoulder System, and joins ZBEdge™ Dynamic Intelligence™, which has the power to enhance the company's cutting-edge digital technologies, robotics and implant solutions.
"We are proud and excited to be the first company in the world to deliver a robotic surgical assistant for anatomic and reverse shoulder replacement surgery,"" said Ivan Tornos, President and Chief Executive Officer at Zimmer Biomet. ""ROSA Shoulder represents a novel advancement intended to help surgeons leverage the power of robotics and data analytics to perform highly complex shoulder procedures with accuracy1 and efficiency."
• ROSA Shoulder is designed to give surgeons the flexibility to execute a total shoulder replacement sing anatomic or reverse techniques and to enable precise placement for improved outcomes1.
• ROSA Shoulder is one of the only systems that can reproduce humeral head resectioning, and can ease insertion of instruments into incisions by requiring no pin in the center of the glenoid during procedures.
• Like all ROSA Robotics applications, ROSA Shoulder is designed to support data-informed physician decision-making based on a patient's unique anatomy.
• Pre-operatively, ROSA Shoulder integrates with the newly released Signature™ ONE Surgical Planning System 2.0, which uses a 3-D image-based approach to visualization, surgical planning and patient-specific guide creation.
• During the surgery, the platform provides surgeons with real-time, intra-operative data to help them control, execute and validate personalized plans for glenoid and humeral placement1, with a goal to reduce complications for patients.2,3,4,5
"One of the challenging aspects of performing a shoulder replacement is accurate glenoid and humeral placement, which is a critical factor for post-operative function and long-term implant survival,"" said John W. Sperling, MD, MBA, Professor of Orthopedic Surgery at Mayo Clinic. ""This innovative approach is designed to allow surgeons to virtually walk through a procedure before making any resections, and then receive live feedback and the ability to control glenoid ream depth and intra-operatively validate cut resections during the procedure."
ROSA Shoulder will be commercially available in the U.S. in the second half of 2024, and will work with the mymobility® Digital Care Management Platform to bolster the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder replacement surgery.
To learn more about ROSA Shoulder, visit zimmerbiomet.com/ROSAShoulder.
• Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health.
• We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence.
• With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers.
• Our legacy continues to come to life today through our progressive culture of evolution and innovation.