Oct 6, 2016 | By Benedict

K2M, a medical device company headquartered in Leesburg, Virginia, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand its CASCADIA Lateral Interbody System. The system uses titanium 3D printed parts, and provides less invasive access to the spine.

Medical device company K2M has rolled out its range of 3D printed Lamellar 3D Titanium medical devices over the last few years, gradually receiving FDA approval for more items in the product range. The technology uses an advanced 3D printing method to create structures with complex geometries, with each 3D printed implant featuring a precise surface roughness (3-5 μm) which encourages bony ongrowth—the organic development of bone on and around the artificial structure. The latest Lamellar technology product to receive FDA approval is an extension of the CASCADIA Lateral Interbody System, an innovation for lateral spine fusions.

K2M’s Lamellar 3D Titanium Technology uses a 3D printing process to create implants with more complex internal structures (500 μm longitudinal channels throughout) than would be possible using other techniques. The CASCADIA implants are made from titanium powder, which is fused through the selective application of a high-energy laser beam, producing complex internal geometries and rough surface architecture that encourages bone growth activity. The developers of the CASCADIA system have taken advantage of this technology to create a 70% porous implant with an increased bone graft volume and similar stiffness to that of K2M PEEK designs. This high level of porosity has the added advantage of a decreased radiographic signature.

The CASCADIA Lateral Interbody System is part of the K2M’s MIS (minimally invasive surgery) portfolio, and provides less invasive access to the spine. The system provides support and stabilization of the lumbar segments of the spine by functioning as an invertebral body fusion device. According to K2M, the reverse hourglass implant design of the CASCADIA system promotes increased endplate contact without sacrificing internal bone graft volume. The system also includes a range of implant sizes and heights designed to accommodate vertebral anatomy, and is intended to work in conjunction with the RAVINE Lateral Access System for the far lateral transpsoas approach.

The CASCADIA system is already widely used by surgeons, and the FDA approval of additional aspects will enable K2M to continue improving the 3D printing process behind the implants in order to assist more patients. “The unique engineering and 3D printing allows the implant to have the biocompatibility and ongrowth characteristics of titanium, while allowing a stiffness that more closely matches bone,” said Greg T. Poulter, MD, an orthopedic spine surgeon at OrthoIndy. “The graft volume and surface area for fusion are generous and the new size options for lordosis allow me to address each patient's individual sagittal plane requirements. CASCADIA has become my go-to implant for lateral interbody fusions.”

 

 

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