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Artoss Gains FDA Clearance of NanoBone SBX Putty for Standalone Use in Fusion

Artoss gained FDA 510(k) clearance to market NanoBone® SBX Putty for standalone use in posterolateral spinal fusion.

NanoBone was tested without addition of autograft or bone marrow aspirate in an animal model and found to be equivalent to the gold standard of autograft in fusion rate.

Artoss Inc. is the exclusive North American distributor for NanoBone in orthopedic surgery applications. James J. Cassidy, Ph.D., Managing Director, said, “The ASTM standard animal model for lumbar intertransverse process spinal fusion is a very challenging model, designed to replicate clinically relevant fusion rates for iliac crest autograft in the posterolateral spine. A majority of bone void fillers must be mixed with autograft in order to achieve equivalent fusion rates to autograft alone. We’re pleased to offer surgeons a synthetic alternative to autograft that does not require mixing with autograft or bone marrow. Using a synthetic bone void filler alone offers significant cost savings to hospitals.”

NanoBone Bone Graft products have been used in Europe and the U.S. for more than 10 years in more than 100,000 clinical cases across all indications.

 



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