NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
NanoFUSE® DBM is a malleable, putty-like, bone-void filler for use in general orthopedic applications. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles, both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe.
At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling process.