SIRAKOSS Receives U.S. FDA 510(k) Clearance for Osteo3 ZP Putty

SIRAKOSS Ltd., a developer of nanosynthetic bone graft substitutes, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Osteo³ ZP Putty, its new nanosynthetic bone graft substitute. Osteo³ ZP Putty has been designed to provide surgeons with an easy-to-use, advanced solution for filling voids or gaps during spine 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. “U.S. 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 unique 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. “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 U.K., 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.”
 
Osteo³ ZP Putty is an entirely synthetic, nanoporous bone graft substitute composed of novel inorganic granules suspended in a fully-synthetic resorbable carrier. The putty has been designed to catalyse rapid and complete bone regeneration and can be used immediately, directly from the pack. This brings important benefits to patients, who will need less time under anaesthetic, and implies savings in theatre time and cost. Successful early pre-clinical studies support the potential for reliably achieving rapid patient recovery. Osteo³ ZP Putty also allows clear imaging of postoperative repair and is readily resorbed once integrated with host tissue.