Medical technology firm Stryker has received 510(k) clearance from the US Food and Drug Administration (FDA) for its intervertebral body fusion device, Tritanium PL posterior lumbar cage.
The new 3D printed cage has been developed to help in lumbar spinal fixation of patients with degenerative disc disease, grade I spondylolisthesis, and degenerative scoliosis.
Developed by using a 3D additive manufacturing process, Tritanium is a porous titanium material designed for bone in-growth and biologic fixation in spine applications.
Tritanium PL cages, which are available in different widths, lengths, heights, and lordotic angles, can be used in a variety of patient anatomies. These are designed to be implanted through a posterior approach.
The cage features large lateral windows and open architecture, which enable visualization of fusion on CT and X-ray.
The solid-tipped and precisely angled serrations of the cage are designed for bidirectional fixation and to enhance surface area for endplate contact with the implant.
Stryker spine division president Brad Paddock said: "We are committed to offering a full range of innovative spinal products that allow surgeons to help their patients return to a more active lifestyle.
"Our advanced 3D additive manufacturing capabilities allow us to precisely manufacture the porous structures of Tritanium and specific implant geometries."
The cage can be used with autograft or allogenic bone graft, including cancellous or corticocancellous bone graft inside the device. It can also be used with supplemental spinal fixation systems that were cleared by the FDA for use in the lumbosacral spine.
The company will commercially introduce the new 3D printed cage in the second quarter of this year.
Image: T1 weighted sagittal cervical spine MRI showing degenerative disc disease. Photo: courtesy of Stillwaterising.