US FDA clears Amend Surgical NanoFuse BA

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Amend Surgical has received US Food and Drug Administration (FDA) 510(K) clearance to market NanoFuse BA as a bone graft extender for spine and orthopaedic applications.

NanoFuse BA is a composite containing 45S5 bioactive glass and a patent-protected carrier that provides optimal surgical handling performance and graft stability. Bioactive glass is intended to facilitate operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis. According to a press release, it creates a highly favourable environment for bone fusion as it remodels into the recipient’s skeletal system.

With this most recent clearance, Amend Surgical now has two FDA-cleared product lines.