US FDA approval granted for two Camber Spine devices

The SPIRA C standalone integrated cervical fixation system

Camber Spine has announced US Food and Drug Administration (FDA) clearance and the nationwide launch for two novel anterior cervical devices, the SPIRA C-Integrated Interbody system, a standalone integrated fixation system, and the FORTICO Anterior Cervical Plating System, a two-screw plating system intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients.

“Camber Spine has spent the last year in aggressive development to create two options for spine surgeons to address anterior cervical pathology. With the addition of SPIRA C Integrated, surgeons now have a zero-profile, screw-fixated interbody option for anterior cervical fusions with all the benefits of the SPIRA open architecture design. Additionally, the surgeon design teams impressed upon the engineers the need for having a minimally invasive cervical plate option in addition to the zero-profile system, which led to the development of the FORTICO plating system,” stated Seth Anderson, chief innovation officer.

FORTICO Anterior Cervical Plating System

FORTICO is a two screw, low profile cervical plate designed to match the anterior face of the SPIRA® interbody system, which is cleared as a cervical plating system. It has the unique ability to be attached to the interbody cage or used independently. The SPIRA C Integrated incorporates Camber Spine’s proprietary technology Surface by Design, a proven osteopromotive surface, according to a recent study conducted by HSS, and its patented arch design for redistribution of load to maximise end plate contact and promote full arthrodesis.

“These two additions will establish Camber Spine as a new leader in 3D printed, arched, open architecture cervical implants and cervical fixation options for the treatment of complex spine pathologies,” continued Seth Anderson.

Camber Spine also recently received additional issued patents from the US Patent and Trademark Office on the SPIRA technology, further strengthening its proprietary position in the open architecture 3D printed implant space.


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