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Nanotherapeutics receives expanded FDA clearance for NanoFUSE

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Nanotherapeutics recently announced its proprietary bone void filler product, NanoFUSE demineralized bone matrix, has received expanded 510(k) marketing clearance from the FDA for use in spinal fusion surgery.

The product has been cleared for use with autograft as a bone graft extender in the posterolateral spine, according to a company press release. The composite allograft is specifically designed to optimize surgical handling performance, graft stability and osteoproductivity, according to the release. Additionally, it is the first off-the-shelf demineralized bone matrix (DBM) product containing bioactive glass available for use in an orthopedic clinical setting.

The putty-like NanoFUSE DBM 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. These gaps may be surgically created osseous defects or a result of prior traumatic injury, according to the release.

Reference: www.nanotherapeutics.com.