FDA approval conceded to Centinel Spine for 3D-Printed FLX Devices

Centinel Spine has invested 510(k) clearance from the FDA to market its FLX Platform of Integrated Interbody and non-integrated interbody fusion devices, an important medical approval increasingly being granted to 3D printed devices as the FDA continues to examine and regulate 3D printing in medical device creation. (Read more Medical Additive Manufacturing news)

The Centinel’s 3D printed FLX devices are made completely from titanium and feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility compared to solid titanium implants. FLX devices also feature a proprietary FUSE-THRU trabecular scaffold which is designed to allow for bony in-growth and on-growth throughout the implant. (Find more Metal Additive Manufacturers in our Business Directory.)