Nvision Biomedical Technologies receives FDA clearance for first osteotomy wedge system

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The US Food and Drug Administration (FDA) has given clearance for the Nvision Trigon Stand-Alone Osteotomy wedge system, made from PEEK-OPTIMA HA Enhanced, a polymer from Invibio Biomaterial Solutions.

Nvision paired with Invibo to create this product, which they claim in a press release has osteoconductive properties that promote multi-directional bone healing, as well as improved fixation without introducing material-related bio-incompatibility reactions.

They also claim that the Trigon allows for a standard surgical technique that allows direct and exact placement of the implant and screws, without any additional plating.

Kyle Vaughn, founder of the Paradise Valley Foot and Ankle, Phoenix, USA, commented on the project, “The Trigon Osteotomy Wedge system, along with the entire foot and ankle line, is incorporating multiple technologies that I believe will be major factors in the future of reconstructive distal extremity surgery.”


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