Amedica Re-files FDA Submission for Modified CsC-based Cervical Implant

By Julie A. Vetalice

Amedica re-filed an application with FDA with a modified cancellous-structured ceramic (CsC)-based cervical implant that is comparable to the Valeo®C cervical implant.

The company also announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company's porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation.

The original filing for a CsC-based implant occurred in 1Q15. In November 2016, the company was notified that FDA did not clear its 510(k) premarket application to commercialize Valeo C+CsC.

Sources: Amedica Corporation; ORTHOWORLD Inc.

 

Product Labels: Cervical Spine

Tags: Regulatory