Zimmer Biomet announces FDA clearance for first 3D printed spinal implant

May 2018

Zimmer Biomet Holdings are global leaders in musculoskeletal healthcare, founded in 1929 and based in Indiana, US. They design, manufacture and market orthopaedic reconstructive products, spine, craniomaxillofacial and thoracic products, dental implants and surgical products. Their ongoing collaborative research and development with healthcare professionals all over the globe means they’re constantly innovating, helping “[…] millions of people live better lives.”

Zimmer Biomet Holdings recently announced they have been granted 510(k) clearance from the United States Food and Drug Administration (FDA) for a new spinal implant product they are bringing to market. The Zystron®️ Strut Open Titanium Interbody Spacer System is the company’s first spinal implant manufactured using 3D printing methods. We’re really excited to see a leading company using 3D printing to bring medical innovations to the market.

“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 New York orthopaedic surgeon Frank Schwab, MD. “I have worked with a variety of Zimmer Biomet’s spine products and am looking forward to offering my patients this latest innovation.”

Medical products go through layers and layers of assessments by the FDA before they are granted clearance for marketing. Zimmer Biomet have produced intricate medical devices using 3D printing in the past, and are fast becoming champions of the process. Last year the company received FDA clearance for a 3D printed ankle fusion system.
As 3D printing is a newcomer process for manufacturing medical products, relatively few 3D printed models have been granted FDA 510(k) clearance, but this looks set to change. In recent years an increase in clearance for such products has been observed, which could point to this method gaining a stronger foothold in the medical industry. This is good news for patients who can benefit from the reduced production costs and flexibility offered by 3D printing.

What is it that makes 3D printing the perfect medium for creating the System? One of the most important benefits is that it allows implants to be created from biocompatible materials, which can reduce recovery time for patients. Rebecca Whitney, General Manager of Zimmer Biomet’s Spine division, says: “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. 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.”

FDA clearance for the Zyston Strut Open Titanium Spacer is the start of a very exciting process for Zimmer Biomet and for spinal patients across the world, and we look forward to seeing where 3D printing can take this latest innovation!

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