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Legal & Regulatory Feature

Courtesy of CTL Corporation

FDA Clears Matisse Titanium Spinal Implant Cage

Biloine W. Young • Tue, October 3rd, 2017

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The CTL Medical Corporation, a Dallas, Texas based firm involved in medical device manufacturing, has received FDA clearance to market its Matisse Titanium CIF Cage implant with TiCro textured surface. The device is used in spine fusion surgery.

The manufacturer claims that the cage, with CTL Medical’s proprietary TiCro surface technology, offers 200% greater endplate contact surface area, as well as bone conforming geometry for increased mechanical locking at the cage and bone interface. The implant has a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes.

“Countless engineering hours and R&D resources went in to developing CTL Medical’s patent pending TiCro™ surface technology, which was designed to expand our current portfolio, advance fusion technologies, and offer spine surgeons numerous surgical advantages,” said Danny Chon, president and CEO of CTL Medical. “The Matisse™ system includes streamlined instrumentation and a variety of footprints, heights and lordotic profiles to accommodate variations in patient anatomy.”

The use of cage devices in spinal surgery began with clinical trials in 1989. The Matisse Titanium ACIF Cage with TiCro is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at the one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

The. Matisse Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. Matisse Titanium ACIF Cage with TiCro is to be used with supplemental fixation, such as CTL Medical’s Van Gogh Anterior cervical plating system, which has been cleared for use in the cervical spine.

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