Nanovis Awarded FDA Clearance for Nano FortiFix Pedicle Screw

By Julie A. Vetalice

Nanovis Awarded FDA Clearance for Nano FortiFix Pedicle Screw

Nanovis received FDA 510(k) clearance for a bioceramic nanotube surface on its Nano FortiFix Pedicle Screw, reportedly the first clearance for a nanotechnology-enhanced pedicle screw system.

The technology offers comparative data in the label, assessing the relative performance of both human osteoblasts and human mesenchymal stem cells on the 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.

"Surgeons and distributors have been very complimentary 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' VP of Sales, Jeff Shepherd.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory