Nanovis Awarded 510(k) for First Nanotechnology Enhanced Pedicle Screw System

Nanovis has received U.S. Food and Drug Administration (FDA) 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,” said 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,” said Nanovis’ Vice President of Sales Jeff Shepherd.
 
Nanovis is a bio-device technology company committed to helping surgeons, hospitals, and patients achieve excellent fixation and infection outcomes using advanced tech platforms. Its 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 is actively expanding distribution for bioceramic nanotube enhanced Nano FortiFix pedicle screws and bioceramic nanotube enhanced Nano FortiCore interbodies. 
 
The company’s last FDA 510(k) clearance occurred last October (2019) for its bioceramic nanotube surface that demonstrated the agency’s requirements for nanotechnology.
 
 “We are delighted to receive such an important designation for this new class of nanotechnology. This nanotechnology plays an important role in achieving Nanovis’ goal to reduce the pain and suffering from implant loosening. With this clearance we can rapidly apply this technology to our entire spinal implant portfolio so that we can help as many patients as possible and promote sales growth for the long-term.” said Hedrick.