Stryker’s Latest 3D Printed Spinal Implant Receives FDA Clearance

3D printing has played a big role in helping those with spinal conditions, and one of the most prominent companies in the 3D printed spinal implant sector has been Stryker. The medical device company debuted its 3D printed Tritanium Posterior Lumbar Interbody Cage in 2016, featuring Stryker’s proprietary Tritanium Technology, and now the company has announced that another of its 3D printed devices, the Tritanium TL Curved Posterior Lumbar Cage, has received 510(k) clearance from the FDA.

The 3D printed spinal implant consists of a combination of solid and porous structures that are simultaneously built using AMagine, Stryker’s proprietary 3D printing technique. The technology is inspired by the structure of cancellous bone and designed so that the implant fuses with the body’s natural bone tissue. Tritanium Technology is also designed for bone ingrowth and biological fixation, featuring a porous titanium material designed to create a favorable environment for cell attachment. The technology has demonstrated that bone cells, or osteoblasts, infiltrated, attached to, and proliferated on the titanium surface. In addition, the material may be able to wick or retain fluid in comparison to traditional titanium material.

“The Tritanium TL Cage is the latest addition to our highly successful Tritanium portfolio, which has been embraced by spinal surgeons nationwide. 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,” said Bradley Paddock, President of Stryker’s Spine division.

Tritanium TL Curved Posterior Lumbar Cage has open central graft windows that help reduce stiffness of the cage, as well as aiding in visualization of fusion and allowing for bone graft containment. It’s shaped for steerability, with multidirectional teeth designed for multidirectional fixation so the surgeon can steer and rotate the cage to their desired placement. The teeth 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 Curved Posterior Lumbar Cage is indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. It should be implanted via a posterior approach. You can find full instructions for use here.

Stryker’s newest 3D printed spinal cage will be available in a wide range of footprints, heights and lordotic angles to fit the anatomy of various patients. It will be available to surgeons in the second quarter of 2018.

Clearances from the FDA are critical for medical 3D printing as the technology continues to advance into healthcare. The government agency has been paying increasing attention to additive manufacturing with issued guidance and a long-term focus.

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[Images: Stryker]