Curiteva’s Inspire Trabecular PEEK standalone anterior lumbar interbody fusion system earned FDA 510(k) clearance, according to a June 24 news release.
The 3D-printed PEEK standalone implant is the first of its kind, and its FDA milestone was driven by Curiteva’s proprietary Master File for Inspire. The Master File helps streamline the regulatory process and validation for the system.
“The results I am seeing and the timeframe in which they are achieved is striking,” Stephen Tolhurst, MD, said in the release. “The implant design and cage technology are truly unique and allow for visual confirmation of bone growth both on and through the implant.”
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