U.S. FDA Clears PearlBone for Bone Fracture Repair, First Nacre-Derived Bone Graft Substitute

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to PearlBone™ Putty 1600, a patented technology developed at The University of Western Australia. This marks the first nacre-derived bone graft substitute to receive FDA clearance for use in repairing bone fractures. Developed using sustainably sourced pearl shell from Western Australia's Kimberley region, PearlBone™ utilizes the natural properties of nacre to support bone repair and regeneration.