FDA clears Stryker Tritanium PL posterior lumbar cage

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The Tritanium PL (posterior lumbar) cage (Stryker, Spine Division) has been granted 510(k) clearance from the US Food and Drug Administration. The cage is intended for use in patients with degenerative disc disease, grade I spondylolisthesis, and degenerative scoliosis.

The cage is made from a highly porous titanium material, Tritanium, which is created via a 3D manufacturing process and designed to promote bone in-growth and biologic fixation in spinal applications.

Tritanium PL Cages are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies and are designed to be implanted via a posterior approach. The large lateral windows and open architecture of the Tritanium PL cage should allow visualisation of fusion on computed tomography and X-ray. Its solid-tipped, precisely angled serrations are designed for bidirectional fixation and to maximise surface area for endplate contact with the implant. The Tritanium PL cage is also designed to address the potential for subsidence into the endplates.

Brad Paddock, president of the Stryker Spine Division, says, “Our advanced 3D additive manufacturing capabilities allow us to precisely manufacture the porous structures of Tritanium and specific implant geometries.”