Stryker receives FDA clearance for intervertebral body fusion device

Stryker Spine recently announced it received 510(k) clearance from the FDA for the company’s Tritanium PL Posterior Lumbar Cage, an intervertebral body fusion device that can aid in lumbar spinal fixation for patients with degenerative disc disease.

The lumbar cage is constructed out of proprietary tritanium technology. Tritanium is a highly porous titanium material designed for bone in-growth and biologic fixation in spine applications. The devices are manufactured via a 3-D additive manufacturing process, according to a company press release. The device is intended for use in patients with degenerative disc disease, grade I spondylolisthesis and degenerative scoliosis.

“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 3-D additive manufacturing capabilities allow us to precisely manufacture the porous structures of tritanium and specific implant geometries. We are pleased to bring this technology to our spine surgeon community and their patients,” Brad Paddock, president of the spine division of Stryker, said in the press release.

Tritanium PL Cage is offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to numerous patient anatomies and are designed to be implanted via a posterior approach, according to the release. The implants will be available in the second quarter of 2016.

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