CTL Amedica Gains FDA Clearance for MONDRIAN LIF Cage

By Julie A. Vetalice

CTL Amedica Gains FDA Clearance for MONDRIAN LIF Cage

CTL Amedica received FDA 510(k) clearance to market its MONDRIAN™ Lumbar Interbody Fusion (LIF) Cage, featuring TiCro™ surface technology.

TiCro surface architecture is a proprietary approach to machined titanium technologies. The surface geometry is intended to enhance interlocking properties and increase bone ingrowth surface area by 200% over predicates.

In the MONDRIAN LIF line, the titanium bullet TLIF and PLIF with TiCro are slated for limited launch in 4Q20, with other formats to follow.

MONDRIAN LIF features a large graft window, radiographic markers, a self-distracting bullet tip and a bi-convex profile and lateral aperture. The system is designed for use with supplemental fixation.

Daniel Chon, CTL Amedica Corporation President and CEO, said, “With multiple material offerings, 15 different cage configurations, 34 footprints, 7 lordotic options and 7,160 part combinations, the sheer breadth of this clearance is a tremendous accomplishment and a testament to our team’s dedication to ‘moving the needle’ in product innovation and design.”

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory