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Zimmer Biomet receives FDA 510(k) clearance for titanium interbody spacer system
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Zimmer Biomet Holdings Inc. announced it has received FDA 510(k) clearance for its Zyston Strut Open Titanium Interbody Spacer System.
A family of lumbar cages designed to enhance strength, graft capacity and visualization of the interbody spacer in spinal fusion cases, the Zyston Strut Open Titanium Interbody Spacer System will be available in a series of sizes to accommodate a range of patient anatomies and surgical approaches, according to a company press release. The release also noted the system includes surgical instruments for insertion, manipulation and removal of the implants.
“The Zyston Strut Open Titanium Spacer is manufactured using a 3-D printing process, which allows us to create a unique cage architecture that maximizes graft volume prior to implantation,” Rebecca Whitney, general manager of Zimmer Biomet’s spine division, said in the release. “The system marks our first 3-D printed titanium spinal implant and adds to our comprehensive offering of lumbar spacers that are available in PEEK-Optima, trabecular metal technology and allograft.”
Reference:
http://investor.zimmerbiomet.com/news-and-events/news/2018/05-22-2018-215951558