Zimmer Biomet Announces 510(k) Clearance for Zyston® Strut Open Titanium Interbody Spacer System
WARSAW, Ind., May 22, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zyston® Strut Open Titanium Interbody Spacer System. This marks Zimmer Biomet’s first titanium spinal implant manufactured via a 3D printing process.
The Zyston Strut Open Titanium System is a family of lumbar cages designed to enhance the strength, graft capacity and visualization of the interbody spacer in spinal fusion cases. The cages will be available in a series of sizes to accommodate a range of patient anatomies and surgical approaches. The System also includes surgical instruments for insertion, manipulation and removal of the implants.
“The Zyston Strut Open Titanium Interbody Spacer System is available in straight and curved profiles and is uniquely designed to provide surgeons with an option that optimizes the balance of strength and graft capacity in spinal fusion cases,” said board certified orthopaedic surgeon Frank Schwab, MD, New York, NY. “I have worked with a variety of Zimmer Biomet’s spine products and am looking forward to offering my fusion patients this latest innovation.”
“The Zyston Strut Open Titanium Spacer is manufactured using a 3D printing process, which allows us to create a unique cage architecture that maximizes graft volume prior to implantation,” said Rebecca Whitney, General Manager of Zimmer Biomet’s Spine division. “The System marks our first 3D printed titanium spinal implant and adds to our comprehensive offering of lumbar spacers that are available in PEEK®-Optima, Trabecular Metal™ Technology and allograft.”
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.
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 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 made. 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.
ZBH-Corp
SOURCE Zimmer Biomet Holdings, Inc.
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