Centinel Spine granted FDA clearance for its metal AM spinal implants

June 13, 2018

June 13, 2018

Centinel Spine granted FDA clearance for its metal AM spinal implants

Centinel’s proprietary FUSE-THRU™ trabecular scaffold allows for bony in-growth and on-growth throughout the implant (Courtesy Centinel Spine, LLC)


Centinel Spine, LLC, West Chester, Pennsylvania, USA, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its FLX™ Platform of Integrated Interbody™ and non-integrated interbody fusion devices. Centinel is said to be the largest privately-held spine company, and is focused on the manufacture of devices for reconstructing the anterior column (the pronounced, ventrally oriented ridge of grey matter in each half of the spinal cord).

The FLX range comprises a number of all-titanium additively manufactured devices which feature a combination of solid and porous radiolucent sections (transparent under X-rays) designed to reduce mechanical stiffness and improve visibility compared to solid titanium implants. The devices also feature the company’s proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.

“We are excited to announce the clearance of the FLX Platform, which represents the next evolution in STALIF technology,” stated John Viscogliosi, Centinel Spine Chairman & CEO. “Utilising AM, we are able to offer the proven benefits of the STALIF design in a truly novel, all-titanium lattice option. This allows our surgeons the flexibility to use multiple implant material options through a single set of instruments to address each patient’s unique pathology.”

STALIF FLX Integrated Interbody devices are said to offer a unique advantage over other all-titanium implants as they are indicated for use at one or two contiguous levels, with both autograft bone grafts, using the patient’s own bone, and allogenic bone grafts, using donated or harvested bone from a second individual.


June 13, 2018

In the latest issue of Metal AM magazine

Download PDF

Extensive AM industry news coverage, as well as the following exclusive deep-dive articles:

  • Metal AM in the aerospace sector: from early successes to the transformation of an industry
  • Slowly but surely: Industrialising metal Additive Manufacturing the Norwegian way
  • Hot Isostatic Pressing and AM: How to improve product quality and productivity for critical applications
  • The convergence of Additive Manufacturing and Artificial Intelligence: Envisioning a future that is closer than you think
  • ADAXIS: On a mission to reduce the layers of complexity in robotic Additive Manufacturing
  • Exploiting your metal Additive Manufacturing data assets: Faster industrialisation and new revenue streams

The world of metal AM to your inbox

Don't miss any new issue of Metal AM magazine, and get the latest industry news. Sign up to our twice weekly newsletter.

Sign up

Discover our magazine archive…

The free to access Metal Additive Manufacturing magazine archive offers unparalleled insight into the world of metal Additive Manufacturing from a commercial and technological perspective through:

  • Reports on visits to leading metal AM part manufacturers and industry suppliers
  • Articles on technology and application trends
  • Information on materials developments
  • Reviews of key technical presentations from the international conference circuit
  • International industry news

All past issues are available to download as free PDFs or view in your browser.

Browse the archive

Looking for AM machines, metal powders or part manufacturing services?

Discover suppliers of these and more in our comprehensive advertisers’ index and buyer’s guide, available in the back of Metal AM magazine.

  • AM machines
  • Process monitoring & calibration
  • Heat treatment & sintering
  • HIP systems & services
  • Pre- & post-processing technology
  • Powders, powder production and analysis
  • Part manufacturers
  • Consulting, training & market data
View online
Share via
Copy link
Powered by Social Snap