Nanovis Gains FDA Clearance of FortiCore Interbodies with Nanosurface Technology

By Julie A. Vetalice

Nanovis received FDA 510(k) clearance to market FortiCore® interbody fusion devices that feature a Nanosurface-enhanced porous titanium scaffold, intermolded with a PEEK core.

The devices are intended for use in transforaminal and anterior lumbar interbody fusion procedures (TLIF and ALIF). The nanopatterned surface is intended to target fixation-related complications; it also forms the basis of a bactericidal program under development to address infection-related complications

FortiCore devices received initial FDA clearance in 2014. Since then, over 4,250 units have been implanted; this is an increase from the milestone of the 2,000th implantation, noted in 1Q17.

Sources: Nanovis; ORTHOWORLD Inc.

Nanovis' FortiCore Interbody Fusion Devices

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory