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Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, 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.

Source: https://www.prnewswire.com/news-releases/zimmer-biomet-announces-510k-clearance-for-zyston-strut-open-titanium-interbody-spacer-system-300652041.html

For Further Information

More on the spinal implants and VCF market in the US can be found in a series of reports published by iData entitled the US Market Report Suite for Spinal Implants and VCF. This report covers the following market segments: traditional cervical and thoracolumbar fixation devices, interbody devices, motion preservation devices, vertebral compression fracture (VCF) treatment, and spinal instrumentation.

The iData series on the market for spinal implants and VCF covers the U.S., Latin America (Brazil, Mexico, Argentina), and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about spinal implants and VCF market data or procedure data, register online or email us at [email protected] for a US Market Report Suite for Spinal Implants and VCF brochure and synopsis