Osteotech's Plexur P Biocomposite for the spine:
This article was originally published in Clinica
Executive Summary
Osteotech has received US FDA 510(k) clearance for its Plexur P Biocomposite for use in the spine. The product is used as a bone filler and bone graft extender, and was cleared in the US for filling bony voids of the pelvis and extremities in February 2007. It is a composite of cortical fibres suspended in a scaffold, available as granules, cylinders, blocks, wedges and sheets. Last month, the FDA cleared the Eatontown, New Jersey-based firm's Plexur M Biocomposite for filling voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Plexus M is a flexible biomaterial that becomes mouldable when heated (see Clinica No 1298, p 18).