Zimmer Biomet Receives FDA Clearance for ROSA® Shoulder System - the World's First Robotic Assistant for Shoulder Replacement Surgery
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The FDA's 510(k) clearance of Zimmer Biomet's ROSA® Shoulder System marks a significant milestone in the medical device industry, particularly in the realm of orthopedic surgery. This clearance indicates that the device is considered safe and effective for its intended use and is substantially equivalent to legally marketed predicate devices. The introduction of the ROSA® Shoulder as a robotic surgical assistant for shoulder arthroplasty is poised to disrupt the current market, offering a novel solution that enhances surgical precision and may improve patient outcomes.
From an investment perspective, Zimmer Biomet's expansion of its ROSA® Robotics portfolio could potentially increase its market share in the surgical robotics space. The integration of the ROSA® Shoulder with the Signature™ ONE Surgical Planning System 2.0 and the mymobility® Digital Care Management Platform reflects the company's commitment to innovation and could lead to increased demand for its products. This, in turn, might drive revenue growth and enhance shareholder value. However, the adoption rate of new medical technologies can be influenced by factors such as cost, surgeon training and clinical evidence supporting the benefits of the technology.
The healthcare industry continually seeks to balance cost with the delivery of innovative and effective treatments. The introduction of the ROSA® Shoulder System could potentially lead to a reduction in operative time and a decrease in post-operative complications, which are key factors in the overall cost of care. By potentially improving surgical outcomes, there may be a downstream effect of reducing the need for revision surgeries and associated healthcare costs.
It is important to consider the economic implications of such a system on the healthcare market. While the initial investment in robotic systems can be substantial for healthcare providers, the long-term benefits, including the potential for shorter hospital stays and quicker patient recovery times, may justify the cost. The adoption of the ROSA® Shoulder System could also have implications for competitors in the orthopedic surgical space, prompting further innovation and potentially leading to price adjustments to maintain competitive advantage.
The technical aspects of the ROSA® Shoulder System, such as its ability to aid in precise humeral head resectioning and glenoid placement without requiring a pin in the glenoid, represent a leap forward in shoulder arthroplasty. The system's design, which allows for the use of either anatomic or reverse shoulder replacement techniques, offers surgeons a high degree of flexibility in addressing a range of patient needs.
Furthermore, the integration with pre-operative planning tools and intra-operative feedback mechanisms can empower surgeons to achieve more consistent and accurate results. This could translate into improved functional outcomes for patients and potentially extend the longevity of the implants. However, the clinical benefits of the ROSA® Shoulder System will need to be validated through rigorous post-market studies and long-term follow-up to confirm its efficacy and safety compared to traditional methods.
The ROSA® Shoulder System Becomes the First-to-Market Robotic Surgical Assistant for Shoulder Arthroplasty and the Fourth ROSA Robotics Application in Five Years
WARSAW, Ind., Feb. 22, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), 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 using 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
To learn more about ROSA Shoulder, visit zimmerbiomet.com/ROSAShoulder.
About Zimmer Biomet
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.
For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visit www.zimmerbiomet.com or follow on LinkedIn at www.linkedin.com/company/zimmerbiomet or X / Twitter at www.twitter.com/zimmerbiomet.
Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
Cautionary Statement Regarding Forward-Looking Statements
This press 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 may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "aims," "anticipates," "plans," "looking forward to," "estimates," "projects," "assumes," "guides," "targets," "forecasts," "continue," "seeks" or the negatives of such terms or other variations on such terms or comparable terminology. Forward-looking statements include, but are not limited to, statements concerning the Company's expectations, plans, intentions, strategies, prospects, business plans, product and service offerings, new product launches, potential clinical successes, and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. Some of these risks and uncertainties can be found in Zimmer Biomet's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent periodic reports filed with the Securities and Exchange Commission (SEC). Copies of these filings are available online at www.sec.gov, www.zimmerbiomet.com or on request from the Company. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in the Company's filings with the SEC. Such forward-looking statements speak only as of the date made, and the Company 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 press release are cautioned not to place undue reliance 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 press release.
References:
1 Data on File FER-JSB231211-01 Rev. A. Cadaveric studies not indicative of clinical performance.
2 Gregory TM, Sankey A, Augereau B, Vandenbussche E, Amis A, Emery R, Hansen U. Accuracy of glenoid component placement in total shoulder arthroplasty and its effect on clinical and radiological outcome in a retrospective, longitudinal, monocentric open study. PLoS One 8(10): e75791, 2013.
3 Chalmers PN, Boileau P, Romeo AA, Tashjian RZ. Revision Reverse Shoulder Arthroplasty. J Am Acad Orthop Surg. 2019 Jun 15;27(12):426-436. doi: 10.5435/JAAOS-D-17-00535. PMID: 31170096.
4 Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):555-62. doi: 10.1016/j.jse.2006.11.004. Epub 2007 May 16. PMID: 17509905.
5 Duethman NC, Aibinder WR, Nguyen NTV, Sanchez-Sotelo J. The influence of glenoid component position on scapular notching: a detailed radiographic analysis at midterm follow-up. JSES Int. 2020 Jan 14;4(1):144-150. doi: 10.1016/j.jses.2019.11.004. PMID: 32195477; PMCID: PMC7075770.
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