SwissGraft X

SwissGraft X is a biocompatible bone mineral matrix made from purified bovine bone mineral granules. It is intended for bone grafting applications including alveolar ridge augmentation, filling periodontal defects, sinus floor elevation, and peri-implant defect filling, often used with guided tissue or bone regeneration products.

SwissGraft X is manufactured from bovine mineral granules with particle sizes of 0.25–0.6 mm, provided in single-use configurations ranging from 0.15 g to 1.5 g. It is sterilized by x-ray irradiation and consists of interconnected macro- and micropores, making it highly porous and hydrophilic. The predicate device (Bio-Oss®) has similar granule composition and sterilization but offers a broader size range (0.25–1.0 mm and 1.0–2.0 mm) and different fill weights (0.125 g to 5.0 g).

Not stated in this summary.

SwissGraft X is substantially equivalent to Geistlich Bio-Oss® (K240661) because both devices share identical intended uses, the same bovine mineral material, identical shape (granules), and identical sterilization method (x-ray). Although SwissGraft X has a narrower granule size range (0.25–0.6 mm versus 0.25–1.0 mm and 1.0–2.0 mm) and different fill configurations, these are minor variations that fall within the predicate's cleared parameters. Performance data from biocompatibility, shelf-life, and structural characterization of the predicate were leveraged, with additional testing confirming that SwissGraft X meets the same specifications for pore structure, liquid uptake, and granule size distribution.