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Osteotech's Grafton DBM (demineralised bone matrix) products

This article was originally published in Clinica

Executive Summary

Osteotech has received US FDA 510(k) clearance for most of its family of Grafton demineralised bone matrix (DBM) products for use as a bone graft extender, bone graft substitute and bone void filler in orthopaedic indications. Covered in the firm's 510(k) application are its Grafton DBM Gel, Putty, Flex, Matrix, Crunch and Orthoblend. The FDA previously cleared the firm's Grafton Plus DBM paste for use in dental and orthopaedic procedures and its private label Viagraf DBM paste for orthopaedic procedures. "We believe Grafton DBM is the only DBM product on the market to receive clearance for all of these indications and-the only DBM product to be cleared as a bone graft substitute," said Sam Owusu-Akyaw, the Eatontown, New Jersey firm's president and CEO.

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