Search Results

NanoFUSE® 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 (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

NanoFUSE® is a malleable, putty-like, bone-void filler. The product is comprised of a synthetic calcium phosphor-silicate particulate material particles (45S5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, medical grade polymer syringe, double-wrapped in peel-back pouches, in a dust cover paperboard carton. An empty sterile syringe for addition of the hydration fluid of choice is also included in the sterile barrier packaging. NanoFUSE® is intended for single patient use only and is non-pyrogenic. Instructions for use are provided by way of a package insert in the paperboard carton. At point of use, the surgeon reconstitutes the product with an appropriate sterile solution of choice (sterile saline, water for injection, or autologous whole blood). 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 mixed with autograft and gently extruded by the surgeon into the bone void. NanoFUSE® is progressively resorbed and replaced by host bone during the osteo-remodeling process.