FDA

Industrial 3D printing with new and old technology.

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According to 3D Printing Media Network, ¨The FDA has approved its first 3D printed talus metal implant designed to replace the main bone in the ankle joint connecting the leg to the foot. The agency issued a green light to New Jersey-based Additive Orthopaedics under humanitarian use for the treatment of avascular necrosis, a progressive condition that can lead to the death of bone tissue following a sudden injury that cuts off blood flow, such as a broken bone or dislocation.¨

Think 3D Printing Is ‘Old’ Tech? ‘PRNT’ Is Proving Otherwise.

Think 3D Printing Is ‘Old’ Tech? ‘PRNT’ Is Proving Otherwise.

3D printed implants

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According to Kristof Sehmke, global communication manager at Materialise Medical, told Design News, “We used several medical tools for this procedure. The cutting guides used for this operation allowed surgeons to cut the donor and recipient bones very precisely. We also used drilling guides that allow the donor bones to be attached to the recipient’s bones more easily and with great accuracy. These cutting and drilling guides are prepared virtually based on CT scans and the surgeon’s indications, as part of the pre-surgical planning. The company  has a legacy of adhering to the highest possible safety standards and has obtained CE Marking Certification for most of its personalized orthopedic and cranio maxillofacial solutions. This includes 3D-printed anatomical models and patient-matched surgical guides and implants. Materialize was also the first company in the world to receive FDA clearance for software intended for 3D printing anatomical models for diagnostic use. This kind of certification helps raise the industry bar to ensure patient safety and transparency on personalized devices’ production.”