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March 6, 2016

FDA grants 510(k) clearance for Stryker’s Tritanium PL posterior lumbar cage

The US Food and Drug Administration (FDA) has granted 510(k) clearance for medical technology firm Stryker's intervertebral body fusion device, the Tritanium PL posterior lumbar cage.

Cervical Spine

The US Food and Drug Administration (FDA) has granted 510(k) clearance for medical technology firm Stryker’s intervertebral body fusion device, the 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 using a 3D additive manufacturing process, Tritanium is a porous titanium material designed for bone in-growth and biologic fixation in spine applications.

“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.”

Tritanium PL cages, which are available in different widths, lengths, heights, and lordotic angles, can be used in a variety of patient anatomies, and are designed to be implanted through a posterior approach.

The cage features large lateral windows and open architecture, which allow visualisation 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.

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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 launch the new 3D printed cage in the second quarter of this year.


Image: Cervical spine MRI showing degenerative disc disease, osteophytes, and osteoarthritis of C5-C6. Photo: courtesy of Stillwaterising.

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