FDA Clears Stryker Spine’s 3D-Printed Tritanium C Anterior Cervical Cage

Stryker’s Spine division announced that its Tritanium C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has received 510(k) clearance from the U.S. Food and Drug Administration.
 
The Tritanium C Anterior Cervical Cage is constructed from Stryker’s proprietary Tritanium In-Growth Technology,¹ a novel, highly porous titanium material designed for bone in-growth and biological fixation.¹ Tritanium material may be able to wick or retain fluid, in contrast to traditional titanium material.²
 
“We are excited to introduce the Tritanium C Anterior Cervical Cage following the successful launch last year of our Tritanium Posterior Lumbar Cage,” said Bradley Paddock, president of Stryker’s Spine division. “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 our customers have come to expect.”
 
The unique porous structure of the Tritanium material is designed to create a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study.^3* It is inspired by the microstructure of cancellous bone⁴ and enabled by AMagine, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.
 
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. In addition, the large graft window allows for bone graft containment. Engineered for stability,⁵ the cage has serrations on the superior and inferior surfaces designed for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges help to facilitate insertion and protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to adapt to a variety of patient anatomies. It will be available to surgeons in Q4 2017.
 
Intended Use (US)
The Tritanium C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc. The cage is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. For the full indications for use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.
 
References
¹PROJ43909: Tritanium technology claim support memo
²RD0000050927: Tritanium material capillary evaluation
³RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
⁴Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
⁵PROJ44960: Coefficient of friction memo