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

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 for Preppers: Investment Casting with PolyCast Filament

U.S. Energy Department Awards QuesTek $1.2M for Ultra-high Temperature 3D Printing Metals



Categories

3D Design

3D Printed Art

3D Printed Food

3D Printed Guns


You May Also Like

NIST Awards $4M to Four Institutions for Metal 3D Printing Research

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST), a non-regulatory agency that promotes innovation and industrial competitiveness across the country, has awarded close to $4 million...

Xerox’s PARC to Use AlphaSTAR Simulation to 3D Print Turbomachinery Parts

California-based Palo Alto Research Center (PARC), a Xerox-owned research and development subsidiary company, has selected AlphaSTAR technology to create a virtual additive manufacturing (AM) approach that will save both time...

Air Force Awards Optomec $1M for High Volume 3D Printing Repair of Turbines

Optomec, a leading provider of additive manufacturing repair solutions, has won a $1 million contract from the U.S. Air Force to produce a system for the refurbishment of turbine engine...

3D Printed Turbine Combines 61 Parts into One

In July this year, Velo3D had qualified a new nickel-based alloy, Hastelloy X, due to its suitability in the additive manufacturing of power generation components such as gas turbines, using...


Shop

View our broad assortment of in house and third party products.