AMS Spring 2023

Emerging Implant Technologies Receives New FDA Clearance for 3D Printed Implants

6K SmarTech

Share this Article

There are several companies out there specializing in the treatment of spinal conditions using 3D printed implants, but one that stands out is Emerging Implant Technologies (EIT), a German company that holds the distinction of being the first medical device manufacturer in the orthopedic field to exclusively focus on implants made using additive manufacturing. EIT’s specialty is its Cellular Titanium technology, a porous titanium material whose structure is close to that of cortical and cancellous bone. Its design facilitates the regrowth and incorporation of natural bone, and has made a major impact on the medical field and on the patients who have benefited from treatment with the implants.

Celluluar Titanium spinal implants were given FDA clearance last year, and now EIT has received FDA clearance again, this time for the expansion of their EIT Cellular Titanium Cervical Cage to be used in multiple contiguous cervical levels (C2 to T1). The design of the cervical cage assists the surgical and biomechanical challenges of cervical multi-level fusion by adapting to maximized vertebral endplate contact and sagittal balance restoration. 

The implants’ fusion potential is supported by EIT’s proprietary 3D printing process, which includes post-printing etching procedures and allows for unique porous structures that cannot be manufactured with traditional manufacturing techniques.

“This is another important regulatory milestone for EIT,” said Guntmar Eisen, Founder and CEO of EIT. “Only very few cervical cages are approved for multilevel use and we are poised to quickly enter the US market with the most advanced technology and state of the art FDA labeling and compliance.”

The EIT Cellular Titanium Cervical Cage is the first multi-level 3D printed cervical cage to enter the US market. It is designed to be used with autogenous and/or allogenic bone grafts to facilitate fusion, and should be used with supplemental fixation.

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) assisted EIT on its FDA strategy and submission.

EIT Cellular Titanium

“This clearance represents continued synergy between FDA and the medical community,” said Justin Eggleton, Senior Director of Regulatory Affairs. “The expanded indications to multiple levels in the cervical spine facilitates improved surgeon collaboration and the ability to collect data that will strengthen the total product lifecycle, which ultimately benefits patients.”

Spinal conditions have always been difficult to treat, which is why technology like that offered by EIT is so exciting. The company’s Cellular Titanium implants not only replace but help to regrow bone, leading to faster and more complete healing. EIT has plenty more innovations coming to the market before long, too. In the second quarter of this year, the company plans to add to its product portfolio with a lateral lumbar cage in the second quarter of 2018 and a fully 3D printed lateral expanding cage in the fourth quarter.

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts below.

[Images: EIT]

 

Share this Article


Recent News

3D Printing News Unpeeled: Warhammer, AVIC and Pearson Lloyd

Fire at Icon’s House 3D Printing HQ Highlights Need for Decentralized Supply Chains



Categories

3D Design

3D Printed Art

3D Printed Food

3D Printed Guns


You May Also Like

Concrete Dreams: Let’s 3D Print Money, not Houses

I’m rather unsure about the potential of 3D printing houses. I know that it is the right thing for the press: additively manufacturing (AM) homes and solving the housing crisis...

How Can 3D Printing Alleviate the Construction Industry’s Social, Climate, and Environmental Challenges?

Global housing shortages, a lack of skilled workers, and the need to reach carbon neutrality by 2050—the construction industry faces a tripled-edged sword. Industry leaders must use their experience to...

3D Printing News Unpeeled: ICON, RAF, Renishaw and Stratasys

Stratasys gets a Victrex PAEK material for its 450MC system, a bunch of new colors of Ultem 9085, a flame retardant polycarbonate and more. The OpenAM software will also let...

Fleet of 3D Printers Begin Building Housing Community in Texas with Construction Giant Lennar Corp and ICON

As 2022 comes to an end, additive construction (AC) companies all over the world are announcing a flurry of upcoming projects. The most recent of these is also one of...