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Titan issued FDA clearance to launch cervical fusion offering

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Titan Spine recently announced it has received 510(k) clearance from the FDA to commercially release its Endoskeleton TCS, an interbody fusion device for the cervical spine with integrated fixation.

The TCS utilizes the company’s proprietary surface technology, which is designed to participate in the fusion process by creating an osteogenic response to the implant’s topography, according to a company release.

Designed for integrated fixation, the device features two surface-enhanced screws that enable immediate implant mechanical stability. The screws have an anti–back-out feature that do not lock the screws to the implant and allow for up to 39° of medial-lateral and 29° of anterior-posterior angulation following implantation, the release stated.

The first surgery using the Endoskeleton TCS was performed on Feb. 9, 2015, at Saint Francis Memorial Hospital in San Francisco by Titan Spine’s chief medical officer, Paul Slosar, MD.

Reference: www.titanspine.com.