Mar 8, 2018 | By Benedict

Stryker, a medical technology company headquartered in Michigan, has received 510(k) clearance from the U.S. Food and Drug Administration for its 3D printed Tritanium TL Curved Posterior Lumbar Cage. It will become available in Q2 2018.

3D printing is helping surgeons of all disciplines refine their craft with more accurate surgical planning and stronger, more biocompatible implants. Those in the business of spinal surgery are no exception, and medical tech company Stryker has just introduced a new 3D printed solution for lumbar fixation procedures.

Their product, which has just been given 510(k) clearance from the U.S. Food and Drug Administration, is the Tritanium TL Curved Posterior Lumbar Cage, a 3D printed interbody fusion cage made for use as an aid in lumbar fixation. The hollow implant consists of a unique configuration of solid and porous structures, both of which are 3D printed using AMagine, Stryker’s proprietary additive manufacturing process for implant creation.

Stryker says its AMagine 3D printing technology, which has been used to make other 3D printed implants, is deliberately designed for fusion and inspired by the microstructure of cancellous bone.

The so-called “Tritanium” of the 3D printed implant is a novel, highly porous titanium material designed for bone ingrowth and biological fixation. Stryker says this in-growth technology has demonstrated that bone cells can infiltrate, attach to, and proliferate on Tritanium’s porous surface. Stryker adds that this Tritanium material “may be able to” wick or retain fluid better than 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,” commented Bradley Paddock, President of Stryker’s Spine division. “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.”

Stryker’s 3D printed Tritanium TL Curved Posterior Lumbar Cage features open central graft windows and lateral windows to help reduce stiffness of the cage, also aiding in visualization of fusion and allowing for bone graft containment.

The multidirectional teeth of the implant are designed for multidirectional fixation, as the cage can be steered and rotated to the surgeon’s desired placement. These teeth are also designed to maximize surface area for endplate contact with the implant.

The 3D printed Tritanium cage has a smooth, tapered leading edge to improve insertion and structural integrity. It will be available in a range of footprints, heights, and lordotic angles to suit individual cases, and will be available to surgeons in Q2 2018.



Posted in 3D Printing Application



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