FG Bone Graft M

FG Bone Graft M is a synthetic bone grafting material composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate in a microporous and macroporous biphasic ceramic form. It is intended to fill, augment, or reconstruct periodontal and oral/maxillofacial bone defects, including periodontal defects, ridge augmentation, implant site preparation, sinus lifts, and cystic cavity filling.

FG Bone Graft M has the same composition (60% HA, 40% β-TCP), porosity (~70%), particle size distribution (0.5–1.0 mm and 1.0–2.0 mm), physical morphology (interconnecting pore structures), crystallinity (>70%), and sterilization method (gamma irradiation) as the predicate MBCP device. The main difference is that FG Bone Graft M is available in Small and Medium granule sizes, whereas MBCP includes Small, Medium, and Large; however, FG's size range falls within MBCP's range.

ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10993-23, USP 151, ASTM F1140, ASTM F88, ASTM F1929, ISO 11137-1, and ISO 11137-2.

FG Bone Graft M is substantially equivalent to MBCP because both devices have identical chemical composition, similar physical properties (porosity, crystallinity, particle morphology), comparable performance in vivo (bone formation and degradation rates), and equivalent biocompatibility profiles. Although FG Bone Graft M offers a narrower range of granule sizes, this narrower range presents no new safety or effectiveness concerns since it remains within the predicate's specification range. The in vivo animal study directly comparing FG Bone Graft M to MBCP showed comparable bone healing, material degradation, and minimal inflammatory response.