SIRAKOSS Receives FDA Clearance for Osteo3 ZP Putty

By Julie A. Vetalice

SIRAKOSS Receives FDA Clearance for Osteo3 ZP Putty

SIRAKOSS FDA 510(k) clearance to market Osteo3 ZP Putty, a new nanosynthetic bone graft substitute for filling voids or gaps during spine and trauma bone grafting procedures.

The putty features a unique surface chemistry designed to catalyze rapid and complete bone regeneration.

Osteo3 ZP Putty is an entirely synthetic, nanoporous bone graft substitute comprising novel inorganic granules suspended in a fully synthetic resorbable carrier that can be used directly from the pack. This offers a benefit of less patient time under anaesthetic, yielding lower O.R. time and cost.

“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.”

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory