Nanovis Awarded 510(k) for Nano FortiFix® the First Nanotechnology Enhanced Pedicle Screw System.
First Ever Pedicle Screw System with Nanotechnology Designation and Osteoblast and Stem cell data comparing performance to other surface types.
Nanovis’ bioceramic nanotube surface on a Nano FortiFix pedicle screw system.
CARMEL, Indiana (April 29, 2020) – Nanovis today announced that it received 510(k) clearance for a bioceramic nanotube surface on its Nano FortiFix Pedicle Screw System.
“Nanovis continues to advance innovative technology platforms to improve patient care. We are very pleased to receive the first FDA clearance for a nanotechnology enhanced pedicle screw system. This technology uniquely offers comparative data in the label assessing the relative performance of both human osteoblasts and human mesenchymal stem cells on our bioceramic nanotube surface against both conventional and micron rough titanium surfaces, with or without an acid etched nanoroughness, and with or without a calcium phosphate coated surface. We are particularly grateful to our scientists and innovative surgeon partners for guiding this technology to the market where it can benefit patients,” says Nanovis CEO, Matt Hedrick.
“Surgeons and distributors have been very complementary of the nanotechnology benefits of our Nano FortiCore interbodies and have requested to pair them with nanotechnology enhanced pedicle screws. We plan to offer a complete portfolio of nanotechnology enhanced pedicle screw systems to include open, percutaneous, midline, and deformity, to give patients the most advanced technology possible,” says Nanovis’ VP of Sales, Jeff Shepherd.
Nanovis is an award-winning bio-device technology company committed to helping surgeons, hospitals, and patients achieve excellent fixation and infection outcomes using advanced tech platforms. Its industry-leading fixation technologies offer surgeons and hospitals the best aspects of fixation, visualization, and durability. Nanovis’ developmental infection technology platforms promise to offer surgeons and hospitals much-needed bactericidal solutions.
Nanovis discovers, develops, and commercializes innovative technology platforms designed for superior fixation and infection outcomes. Nanovis is commercializing the following innovative technology platforms: a bioceramic enhanced nanotube surface, a deeply porous titanium scaffold (licensed from Sites Medical), a pre-clinical bioceramic bactericidal nanotube surface technology, and a pre-clinical localized infection technology potentially capable of killing multi-drug resistant bacteria within minutes.
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