Nanotherapeutics’ NanoFUSE demineralised bone matrix receives expanded 510(K) marketing clearance


Nanotherapeutics’ proprietary bone void filler product, NanoFUSE demineralised bone matrix, has received expanded 510(k) marketing clearance from the US Food and Drug Administration (FDA) for use in spinal fusion surgery. Specifically, NanoFUSE has been cleared for use with autograft as a bone graft extender in the posterolateral spine.

NanoFUSE is a novel composite allograft expressly designed to optimise surgical handling performance, graft stability, and osteoproductivity. Nanotherapeutics says it is the first off-the-shelf demineralised bone matrix product containing bioactive glass available for use in an orthopaedic clinical setting. As an adjuvant to bone matrix, bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis. In particular, the combined properties of the matrix and bioactive glass come together to create a highly favourable environment for bone fusion, as it remodels into the recipient’s skeletal system.

The malleable, putty-like NanoFUSE bone matrix is placed by the surgeon into bony voids or gaps within the skeletal system that are not intrinsic to the stability of the bony structure (eg. the extremities, pelvis and, as a bone graft extender, posterolateral spine). These gaps may be surgically created osseous defects or a result of prior traumatic injury. NanoFUSE is formulated so that it reconstitutes into a paste upon addition of a sterile fluid, such as saline, water for injection and/or autologous blood. The product is supplied as a pyrogen-free implant, in a sterile, single-use, pre-filled syringe, immediately ready for reconstitution.