FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute

FIBERGRAFT BG Putty and related bone graft substitutes are resorbable, biocompatible bone void fillers made from 45S5 bioactive glass mixed with absorbable/polymeric carriers. They are gently packed into non-load-bearing bony voids or gaps in the skeletal system (spine, extremities, pelvis) to fill defects from benign bone cysts, tumors, surgical creation, or traumatic injury, and resorb while being replaced with bone during healing.

The devices are composed of 45S5 bioactive glass components combined with bovine type I collagen and/or absorbable polymeric carriers. FIBERGRAFT BG Putty GPS is provided in a spindle drive syringe compatible with a GPS Cannula. AERIDYAN Matrix and BG Matrix variants are hydrated with saline, blood, or bone marrow aspirate before application. All variants are non-structural scaffolds intended for non-load-bearing applications.

Not stated in this summary.

The subject devices are substantially equivalent to their predicate devices because they are identical in materials, manufacturing process, sterilization, and packaging. The only modification is expansion of the indications for use statement to explicitly include "benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old)." All pre-clinical testing from previous 510(k) clearances remains applicable, and no technological changes were made to the devices themselves.