FDA Clears Stryker Spine’s 3D-Printed Curved Posterior Lumbar Cage

Stryker’s Spine division announced that its Tritanium TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion cage intended for use as an aid in lumbar fixation, recently received 510(k) clearance from the U.S. Food and Drug Administration.
 
Stryker’s Tritanium TL Curved Posterior Lumbar Cage is a hollow implant that consists of a unique configuration of both solid and porous structures, which are simultaneously built using AMagine. AMagine is Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing. The technology is deliberately designed for fusion and inspired by the microstructure of cancellous bone.¹
 
The Tritanium TL Cage features Stryker’s Tritanium Technology,² a novel, highly porous titanium material designed for bone ingrowth and biological fixation.1 This In-Growth technology has demonstrated that osteoblasts (bone cells) infiltrated, attached to, and proliferated on the porosity of the Tritanium technology.³ The unique porous structure is designed to create a favorable environment for cell attachment. Furthermore, the Tritanium material may be able to wick or retain fluid in comparison to traditional titanium material.⁴ The Tritanium TL cage complements the Tritanium PL cage, and together they offer alternative posterior lumbar solutions for spinal surgeons.
 
“The Tritanium TL Cage is the latest addition to our highly successful Tritanium portfolio, which has been embraced by spinal surgeons nationwide,” said Bradley Paddock, president of Stryker’s Spine division. “The TL cage is accompanied by a new Anterior Placement System that is designed for versatility and procedural flexibility. From instrumentation ergonomics and visualization, to a simplified technique with tactile feedback, Tritanium TL’s Anterior Placement System and cage design redefine implant steerability for surgeons.”
 
The Tritanium TL Curved Posterior Lumbar Cage features open central graft windows and lateral windows to help reduce stiffness of the cage, aid in visualization of fusion, and allow for bone graft containment. Shaped for steerability,⁵ its multidirectional teeth are designed for multidirectional fixation as the cage can be steered and rotated to the surgeon’s desired placement. They are also designed to maximize surface area for endplate contact with the implant. The cage has a smooth, tapered leading edge to facilitate insertion into the intervertebral space and a central column spanning endplate to endplate for structural integrity. The Tritanium TL Cage will be available in a broad range of footprints, heights, and lordotic angles to address varying patient anatomy. It will be available to surgeons in Q2 2018.
 
References
¹Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
²PROJ43909 | Tritanium technology claim support memo
³RD0000053710: Tritanium cell infiltration and attachment experiment
⁴RD0000050927: Tritanium material capillary evaluation
⁵PROJ44960 | Coefficient of friction memo