Sirakoss, a developer of nanosynthetic bone graft substitutes, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for Osteo3 ZP Putty, a nanosynthetic bone graft substitute. Osteo3 ZP Putty has been designed for use in the treatment of spinal and trauma bone grafting procedures.
“Osteo3 ZP Putty brings patented, best-in-class handling properties to enhance Sirakoss’ exceptional nanosynthetic bone regeneration potential, giving surgeons a one-two punch of repair confidence and intraoperative ease-of-use for spine and trauma bone grafting applications,” said Tom Buckland, director of Sirakoss. “US FDA clearance is obviously a major achievement for Sirakoss, enabling us to implement the commercial strategy for this game-changing product.”
Synthetic bone grafts are used to fuse bones together during surgery to correct congenital or degenerative conditions, such as curvature of the spine, or following a traumatic injury where the bone fails to heal. Osteo3 ZP Putty has a surface chemistry designed to catalyse rapid and complete bone regeneration following these procedures.
“Our Osteo3 ZP Putty has demonstrated excellent pre-clinical performance in models of spinal fusion and trauma repair,” explained Iain Gibson, co-founder and director of R&D at Sirakoss and Professor of Acellular Regenerative Medicine at Aberdeen University (Aberdeen, UK). “Being able to provide surgeons with the synthetic bone graft in a pre-packed syringe, saves time and is far easier to handle during the procedure in the operating room environment. This product was developed with grant funding support from Innovate UK, part of the United Kingdom Research and Innovation (UKRI) organisation, and we’d like to thank them for their continued support in the development of this more advanced, next generation product.”