Prosidyan, a developer of proprietary fibre-based bioactive glass products, has received US Food and Drug Administration (FDA) 510(k) clearance for its Fibergraft bone graft (BG) putty, a bone graft substitute for posterolateral spinal fusion.
Fibergraft BG pulty is the second generation product in the company’s Fibergraft line of bioactive glass based products. The product is designed to use the direct connectivity of fibres with an exponentially increased surface area and higher resorption rates by virtue of the company’s proprietary bioactive carrier, Ossiglide.
Babak Barcohana of the Southern California Orthopedic Institute commented, “I have had outstanding clinical results with Fibergraft BG morsels over the last three years and look forward to continued clinical success with this next generation product.”
Stephen Tolhurst of the Texas Back Institute, Plano, USA commented, “Fibergraft BG putty is backed by great science and pre-clinical results. It is the only synthetic bone graft I feel comfortable using without mixing with bone marrow aspirate, making it easy to use in surgery.”
Brian Kwon from New England Baptist Hospital, Boston, USA, called the BG putty, “the most intelligent bone graft on the market.”
The putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that is designed to resorb and be replaced with bone during the healing process.