Zimmer Biomet 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."