Zimmer Biomet Holdings (ZBH) Granted FDA Clearance for ROSA Partial Knee System for Robotically-Assisted Partial Knee Arthroplasty

Zimmer Biomet Holdings, Inc. (NYSE: ZBH), a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Partial Knee System for robotically-assisted partial knee replacement surgeries. The ROSA Partial Knee System is the newest addition to ROSA Robotics, Zimmer Biomet's multiple application robotics platform which includes the ROSA Knee System for total knee replacement surgery and ROSA ONE® for neurosurgical and spine procedures. The Rosa Partial Knee System is also now a component of ZBEdge, bringing another robotic solution to Zimmer Biomet's suite of integrated digital and robotic technologies.

The ROSA Partial Knee System is designed for compatibility with Persona® Partial Knee, a market-leading1 partial knee implant system with a clinically proven legacy2,3 and a high rate of patient satisfaction4. Zimmer Biomet has more than 45 years of experience in partial knee arthroplasty and currently holds more than 50 percent of the global partial knee market share.1

Often, only one side of the knee is damaged, thereby making partial knee replacement potentially a better option for patients because it can preserve the undamaged side of the knee. Other benefits of Partial Knee Replacement include retention of the ACL, better range of motion5,6 shorter hospital stays7 and a lower risk of postoperative complications8. Research also shows that 50 percent of knee replacement patients are candidates for partial knee surgery,9 however, today only 10 percent of knee replacement patients receive a partial knee replacement10.

"Working with ROSA Partial Knee, I am able to perform a partial knee procedure with confidence through a simplified technique and incredible accuracy. By minimizing variability across each patient's case, I am better equipped to ensure positive treatment outcomes which can lead to greater patient satisfaction," said David Miller Sr., M.D., an orthopedic surgeon based in Richmond, Virginia. "For surgeons specializing in outpatient joint replacements in a hospital or ambulatory surgery center, the ROSA Partial Knee System can streamline the procedure to improve efficiency and better address the unique needs of each joint replacement patient."

"The FDA clearance of the ROSA Partial Knee System just two years after the introduction of the ROSA Total Knee System builds on the success of our ROSA robotics portfolio, which is designed to help enhance surgical accuracy, precision and efficiency, through the use of intraoperative data that can personalize each procedure. As a result, the ROSA Partial Knee System empowers patients to truly get the knee that's the best fit for their needs," said Ivan Tornos, Chief Operating Officer at Zimmer Biomet. "The ROSA Partial Knee System is the latest innovative component of ZBEdge, our suite of seamlessly integrated technologies, that combines data analytics, robotics, and connected devices and services to inform care decisions. We're excited about these bold new technologies and the role that Zimmer Biomet can play in reshaping orthopedic procedures and restoring patients' quality of life."

The ROSA Partial Knee System features proprietary 2D to 3D X-Atlas™ imaging technology and real-time, intraoperative data collection on soft-tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, which may improve flexion and restoration of natural joint movement.

The Rosa Partial Knee System is the latest addition to ZBEdge, Zimmer Biomet's suite of integrated digital and robotic technologies, purposefully engineered to deliver data-powered clinical insights, shared seamlessly across the patient journey. Intra-operative data collected by the ROSA Partial Knee system can be combined with pre- and post-operative data collected by mymobility® with Apple Watch®, a remote care management platform. This data can then be consolidated and analyzed by OrthoIntel, an orthopedic intelligence platform designed to uncover new clinical insights throughout the episode of care and help surgeons and care teams make informed decisions and optimize care. Calibrated to the needs of patients and care teams, Zimmer Biomet technologies like ROSA robotics are designed to work together to unlock new value and new capabilities, create new efficiencies and improve patient outcomes.

To learn more about how the ROSA Partial Knee System can support your clinical practice, please visit zimmerbiomet.com/rosapartial.

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