Osteotech Inc. has received FDA approval for its 510(k) submission for its Plexur M(TM) Biocomposite. Plexur M is intended for use in filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. During the healing process, Plexur M is remodeled and replaced by host bone. When heated, Plexur M becomes moldable and pliable, which allows surgeons various options for use during surgery. During the cooling process, Plexur M hardens, providing a versatile porous scaffold to help in regeneration of damaged and diseased bones.

Osteotech’s president and CEO Sam Owusu-Akyaw has indicated that the company intends to file an additional submission for the use of this product in spinal applications during the second quarter of the year.