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Stryker receives FDA 510 (k) clearance for 3-D printed anterior cervical cage
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Stryker’s Spine division announced it has received FDA 510 (k) clearance for its Tritanium C Anterior Cervical Cage, a 3-D printed interbody fusion cage intended for use in the cervical spine.
According to a company press release, the Tritanium C Anterior Cervical Cage features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence, while a large graft window allows for bone graft containment. Serrations on the superior and inferior surfaces were designed for bidirectional fixation and to maximize surface area for endplate contact with the cage, the release noted. Offered in a number of footprints, heights and lordotic angles to adapt to a variety of patient anatomies, the Tritanium C Anterior Cervical Cage has smooth posterior edges to help facilitate insertion and protect soft tissue and anatomy.
“We are excited to introduce the Tritanium C Anterior Cervical Cage following the successful launch last year of our Tritanium Posterior Lumbar Cage,” Bradley Paddock, president of Stryker’s Spine division, said in the release. “The benefits of additive manufacturing to create highly porous spinal implants that are ‘engineered for bone’ are becoming increasingly clear. Additive manufacturing allows us to push beyond conventional manufacturing techniques to address design complexity and achieve previously unmanufacturable geometries, while delivering the performance, reproducibility and quality out customers have come to expect.”
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