SpineVision Gains FDA Clearance, CE Mark for HEXANIUM TLIF Cage

By Julie A. Vetalice

SpineVision received FDA 510(k) clearance and CE Mark approval for its 3D-printed, titanium HEXANIUM transforaminal lumbar interbody fusion (TLIF) cage.

The next generation HEXANIUM TLIF cage combines a titanium surface—designed for rapid osseointegration—along with a porous, honeycomb-like structure to maximize bone ingrowth and ongrowth from endplate to endplate, according to SpineVision. The cage is also designed to reduce the risk of subsidence in disc height, post-op.

The device is the first in a line of 3D-printed implants SpineVision plans to introduce.

Sources: SpineVision

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, CE Mark, Regulatory