Centinel Spine granted FDA clearance for its metal AM spinal implants
June 13, 2018
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.
