CTL Amedica has received official 510(k) clearance from the US Food and Drug Administration (FDA) to market its MONDRIAN anterior lumbar interbody fusion (ALIF) cage system with supplementary fixation plate.
The MONDRIAN ALIF cage system with supplementary fixation plate, 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 MONDRIAN offering, features CTL Amedica’s proprietary TiCro surface technology, which, according to the company, significantly increases endplate contact surface area and enhances interlocking properties.
Daniel Chon, CEO of CTL Amedica, said: “This innovative product is designed to provide exceptional anterior column stabilisation and supplemental fixation, while providing operative flexibility and accommodating a wider range of patient anatomies.”
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 maximises graft volume, say CTL Amedica. The system introduces hyperlordotic offerings to the company’s 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, state the firm.