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Stryker's Tritanium C Anterior Cervical Cage gets FDA nod

por Lauren Dubinsky, Senior Reporter | September 25, 2017
3D Printing Business Affairs
Styker announced last Wednesday that its 3-D-printed Tritanium C Anterior Cervical Cage has scored FDA clearance for cervical interbody fusion procedures.

It was constructed with the company’s proprietary Tritanium In-Growth Technology, which is a highly porous titanium material used for bone in-growth and biological fixation. Unlike standard titanium material, Tritanium has the potential to wick or retain fluid.

An in vitro study demonstrated that the porous structure of this material creates a favorable environment for cell attachment and proliferation. Its design was inspired by the microstructure of cancellous bone.

The material was created using Stryker’s proprietary approach to 3-D implant printing called AMagine. According to Bradley Paddock, president of the company’s spine division, 3-D printing allows them to achieve geometries that could not be manufactured previously.

The Tritanium C Anterior Cervical Cage features an open central graft window and lateral windows to help lessen the cage’s stiffness and reduce subsidence. The large graft window also enables bone graft containment.

The cage has serrations on the superior and inferior surfaces that are designed for bidirectional fixation and to maximize the surface area for endplate contact. Its smooth posterior edges make insertion easier and protect the patient’s soft tissue and anatomy.

This cage is intended for use in skeletally mature patients with degenerative disc disease at one level or two contiguous levels from the C2 to T1 disc. It must be used along with a autogenous and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

It’s available in a range of footprints, heights and lordotic angles to adjust to fit patient anatomies. It will be commercially available to surgeons in Q4 of this year.

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