Zimmer Biomet Receives FDA Clearance for ROSA® Partial Knee System for Robotically-Assisted Partial Knee Arthroplasty

WARSAW, Ind., April 20, 2021 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: 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 legacy^2,3 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 motion^5,6 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.

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; office-based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

Apple Watch® is a trademark of Apple, Inc., registered in the U.S. and other countries.

ZBH-Corp

¹ Data on File at Zimmer Biomet. Global Knee Market Model 2020.
² Foran, JR. et al. Long-term Survivorship and Failure Modes of Unicompartmental Knee Arthroplasty. Clin Orthop Relat Res. 2013 Jan; 471(1): 102–108.
³ Berger, RA. et al. Results of unicompartmental knee arthroplasty at a minimum of ten years of follow-up. J Bone Joint Surg Am. 2005 May;87(5):999-1006.
⁴ Persona® Partial Knee Clinical Outcomes Study ANNUAL REPORT K.CR.I.G.16.16. Internal data on file at Zimmer Biomet. Sept 2019.
5. Amin A, et al. Unicompartmental or Total Knee Replacement? A Direct Comparative Study of Survivorship and Clinical Outcome at Five Years. JBJS Br. 2006; 88-B; Suppl 1, 100.
6. Jones, GG, et al. Gait comparison of unicompartmental and total knee arthroplasties with healthy controls. Bone Joint J 2016;(10 SupplB):16–21.
7. Lombardi, A. et al. Is Recovery Faster for Mobile-bearing Unicompartmental than Total Knee Arthroplasty? Clinical Orthopedics and Related Research. 467:1450-57. 2009.
8. Brown, NM, et al. Total Knee Arthroplasty Has Higher Postoperative Morbidity Than Unicompartmental Knee Arthroplasty: A Multicenter Analysis. The Journal of Arthroplasty. (2012).
9. Willis-Owen CA, et al. Unicondylar knee arthroplasty in the UK National Health Service: An analysis of candidacy, outcome and cost efficacy. Knee. 2009 Dec;16(6):473–8
10. UK National Joint Registry Report. 2020.

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

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