K2M’s 3D-Printed Spinal Support Implant Achieves Clearance from FDA

Published by , June 23, 2017 12:28 pm

(3DPrintingIndustry) Medical device company K2M announced that its 3D printed MOJAVE spinal support implant has achieved clearance from the U.S. Food & Drug Administration (FDA). With this certification, the 3D printed implant can now be used inside the body to help correct spinal defects, believed to be the “first-ever” cleared cage of its kind to make it to market. The cage has been produced using K2M’s Lamellar 3D Titanium Technology, essentially a powder-based laser melting approach to metal 3D printing. With the technology, K2M are able to introduce material features conducive to bone growth, including surface roughness of 3–5 μm, and approximately 70% interior porosity.
Explaining the utility of the implant’s features Steven Ludwig, MD, an orthopedic spine surgeon and professor of orthopedics at the University of Maryland Medical Center, comments, “The ability to provide independent control of both the anterior and posterior height separately is desirable for the restoration of sagittal balance compared to existing devices that can’t independently adjust both anterior and posterior height.”

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