FDA Clears PearlBone for Bone Fracture Repair

The U.S. FDA has granted 510(k) clearance to PearlBone™ Putty 1600, a nacre-derived bone graft substitute developed by Marine Biomedical Ltd. This approval allows the technology, sourced from sustainably harvested pearl shell, to be used for repairing bone fractures. This marks a significant regulatory milestone as the first product of its kind to receive such clearance, offering a new option for bone repair and regeneration.