It’s not easy to get a new medical treatment or device to the market – and it shouldn’t be, as these treatments are affecting human lives and need to be 100% proven to be safe and effective before they’re used on people. The FDA has layers and layers of regulations and clearances that a medical device manufacturer in the process of developing a new device, and once the manufacturer believes the device is ready for the market they must submit a 510(k). If the FDA grants 510(k) clearance, the manufacturer can begin marketing the device.
More and more 3D printed medical devices have been receiving 510(k) clearance lately, which is exciting as it shows that 3D printing is gaining a stronger foothold in the medical industry. 3D printing is becoming less of a radical experiment and more of a mainstream means of treatment, whether it’s being used for foot and ankle implants, spinal implants or others. The effectiveness of the technology is being recognized, which is great news for the millions of people for whom conventional treatments aren’t sufficient to relieve their pain.
Some of these devices have come from promising medical startups, but Zimmer Biomet is no newcomer – the massive medical device manufacturer has been in business for more than 90 years, has operations in over 25 countries, and sells products in more than 100 countries around the world. It’s one of the leading medical devices companies in the world, but when it comes to 3D printing, Zimmer Biomet is still on the rise, as it just received 510(k) clearance for its first 3D printed titanium spinal implant.
The Zyston Strut Open Titanium Interbody Spacer System is a series of lumbar cages that are designed to enhance the strength, graft capacity and visualization of the interbody spacer in spinal fusion cases. They will be available in multiple sizes to account for the wide variety in human anatomy as well as in surgical approaches, and will also include 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. “I have worked with a variety of Zimmer Biomet’s spine products and am looking forward to offering my fusion patients this latest innovation.”
It’s encouraging to see a well-established company like Zimmer Biomet turning to 3D printing. Last year the company received FDA clearance for a 3D printed ankle fusion system, and the fact that it is now introducing a spinal implant shows that the company is serious about the technology.
“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.”
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