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news.Pioneer Surgical Technology, a medical device firm, has obtained the FDA approval to proceed to investigational device exemption pivotal study of the NuBac nucleus replacement device for the spine.
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According to the company, the NuBac implant is made of Peek-Optima material which offers well established biocompatibility, biodurability, excellent wear resistance, and radiolucency.
The NuBac implant system is said to be the only nucleus replacement device that utilizes an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions while minimizing extrusion risk.
Matthew Songer, Pioneer’s CEO and chairman of the board, said: “This is a huge milestone and accomplishment for Pioneer to be the first to receive FDA approval to start the investigational device exemption (IDE) pivotal study for nucleus replacement. Many other companies, pursuing nucleus replacement technology, have spent more time and money than Pioneer and have not achieved this significant goal.”