CTL Amedica Gains FDA 510(k) for MONDRIAN ALIF Cage with Supplementary Fixation

CTL Amedica received FDA 510(k) clearance to market its MONDRIAN™ Anterior Lumbar Interbody Fusion (ALIF) Cage with Supplementary Fixation Plate. The system is an integrated plate-and-cage construct that can be manufactured in PEEK, titanium and a hybrid titanium-plated PEEK. The system, a standalone extension to the already robust MONDRIAN offering, features CTL Amedica’s proprietary TiCro™ surface technology, which increases endplate contact surface area and enhances interlocking properties.

The MONDRIAN™ ALIF Cage System with Supplementary Fixation Plate features an efficient screw-locking mechanism, a supplementary screw-blocking plate for additional reinforcement, a significant lateral aperture for improved imaging, and a large central chamber that maximizes graft volume. The system introduces hyperlordotic offerings to the CTL Amedica portfolio and features a smooth and tapered leading-edge for easy insertion and multiple screw plate configurations to better accommodate patient anatomy and surgical preference.

“This innovative product is designed to provide exceptional anterior column stabilization and supplemental fixation, while providing operative flexibility and accommodating a wider range of patient anatomies,” said Daniel Chon, CEO of CTL Amedica. “We’re excited about the FDA approval and look forward to introducing the MONDRIAN™ ALIF Cage System with Supplementary Fixation Plate to the industry this week.”

Source: CTL Amedica