WARSAW, Ind., Jan. 3, 2018 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation. The Sidus Stem-Free Shoulder system is designed to anatomically restore a patient's anatomy, preserve bone stock and allow for improved pre to post-operative patient outcomes1,2. The Sidus system will be available in the United States beginning in the First Quarter of 2018.
"The Sidus Stem-Free Shoulder system offers a novel approach to total shoulder arthroplasty requiring minimal bone resection," said Dr. Ryan Krupp, orthopaedic surgeon at Norton Orthopedic Specialists in Louisville, Ky. "The Sidus system is designed to reduce pain and restore range of motion and is clinically proven to help suitable patients."1,2
"The FDA clearance of the Sidus Stem-Free Shoulder system comes at a time when Zimmer Biomet is accelerating the pace of innovation," said Bryan C. Hanson, Zimmer Biomet President and Chief Executive Officer. "We launched Sidus in Europe in 2012 and initiated a clinical study in the U.S. in 2015. During that time, the product has demonstrated strong clinical performance. The addition of the Sidus system to Zimmer Biomet's U.S. portfolio reinforces the Company's leadership in the innovation of shoulder solutions."
About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic 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.
Cautionary Statement Regarding Forward-Looking Statements This 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 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 release.
1 Multicenter Trial of the Sidus® Stem-Free Shoulder Arthroplasty System (Protocol CIU2012-12E/G130026, "IDE").
2 Sidus® Stem-Free Shoulder: A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study (Clinical Investigation Plan CME2012-01E, "PMCF").