Amedica Receives FDA Clearance of Valeo C+CsC

By Julie A. Vetalice

Amedica received FDA 510(k) clearance of the Valeo C+CsC with Lumen interbody fusion device, a composite implant comprising silicon nitride ceramic in varying densities and an outer shell of solid silicon nitride surrounding a porous core of CsC (Cancellous structured Ceramic).

The device is indicated for use in the cervical spine of skeletally mature patients. Valeo C+CsC device is already used in Europe; the European device design was submitted previously to FDA, and the cleared version is a design modification of the same material, based on feedback provided by FDA. Published clinical data from the CASCADE clinical trial suggest that CsC may achieve spinal fusion without added bone grafts, with success rates at least as favorable as bone autograft.

Source: Amedica Corporation

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory