Spectrum Spine’s next-generation BioBraille nanotechnology earned the FDA’s 510(k) clearance, according to a March 31 news release.
BioBraille is the only FDA-cleared nanotechnology with selective surface capabilities, and it uses a proprietary and advanced laser etching process to “program” nanofeatures on the implant surface.
BioBraille has shown amplified biologic responses in vitro with nanofeatures in a wide size range to promote cellular attachment and early phase bone production.
“BioBraille represents a transformative evolution in nanotechnology, with broad implications across the orthopedic landscape, including reconstruction, sports medicine, trauma, and dental applications,” CEO Kelly Shelton said in the release. “By combining scientific innovation with clinical insight, Spectrum is helping to redefine standards of care.” Spectrum has released its anterior cervical cage incorporating BioBraille, and the release of their expandable interbody cage and family of lumbar cages are imminent.”
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