Stryker’s 3D-Printed Tritanium C Anterior Cervical Cage Gains FDA Clearance

By Julie A. Vetalice

Stryker Spine received FDA 510(k) clearance for its 3D-printed Tritanium® C Anterior Cervical Cage. Launch will begin in 4Q17.

The device features a large open central graft window and lateral windows to help reduce stiffness and minimize subsidence, as well as serrations to enhance fixation and maximize surface area. Smooth posterior edges allow for ease of insertion.

The Tritanium posterior lumbar version of the cage was FDA-cleared and debuted in 1H16.

AMagine™, the company's additive manufacturing approach, allows for the build of a highly-porous titanium material that is not only designed to encourage bone ingrowth and fixation, but may also wick or retain fluid—unlike traditional titanium. Spine and knee are the initial markets of focus for the company's 3D printing efforts, developed in its own dedicated 3D printing manufacturing facility.

Sources: Stryker; ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory