The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement. The device, named Patient Specific Talus Spacer, is the only 3D-printed device in the world, and is designed to treat avascular necrosis of the talus. The approval came after the FDA reviewed data from 31 individuals that had 32 talus replacement surgeries and found that patients on average showed an increase of ankle joint mobility with a decrease in reported pain.
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More on: News Regulatory
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