February 6, 2015 in Advanced Manufacturing, Blog, News from Our Companies

MedShape wins FDA clearance on 3D-printed orthopedic device for bunions

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10300015_726116804113110_9039967487065107619_nThe U.S. Food and Drug Administration (FDA) has approved a 3D-printed device developed by MedShape to help correct bunions.

MedShape, a medical device firm and Graduate Company of the Advanced Technology Development Center at Georgia Tech, said its FastForward Bone Tether Plate is made of a medical grade titanium alloy. The company says the device’s “shape memory” technology protects and keeps intact native bone anatomy.

But beyond that, the 3D printing and shape memory technology has the potential to give surgeons the ability to use biomaterials inside the human body with the development of human-impalatable devices.

“The FastForward system aligns with MedShape’s continued mission to develop and commercialize innovative medical devices from cutting edge materials and manufacturing technologies to address significant clinical needs,” said Ken Gall, MedShape’s chief technology officer and professor of materials science and engineering at the Georgia Institute of Technology. “We are in the early stages of tracking clinical outcomes with this new surgical approach and are excited to extend the 3D printing material platform towards the development of other implants.”

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