Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules

The Mastergraft™ family consists of four bone void filler devices made from biphasic calcium phosphate ceramic (15% hydroxyapatite and 85% β-tricalcium phosphate) combined with collagen (Matrix EXT, Strip, Putty) or ceramic alone (Granules). These sterile, single-use devices are packed into bony voids or gaps in the skeletal system to support bone healing, resorbing and being replaced by bone during the healing process.

The subject devices differ from predicates in material composition—some include collagen while others are ceramic-only—but all maintain the same biphasic calcium phosphate formulation (15/85 hydroxyapatite to β-tricalcium phosphate ratio). The devices are supplied in different physical forms: premixed strips (Matrix EXT, Strip), moldable putty (Putty), or loose granules (Granules), all sterile for single patient use.

Not stated in this summary.

The submission leverages prior 510(k) clearances (K141824, K082166, K071813, K082918) for substantially equivalent reference devices, relying on their established sterility, shelf-life, endotoxin, pyrogenicity, and biocompatibility data per FDA's Class II Special Controls Guidance for Resorbable Calcium Salt Bone Void Filler Devices. The expansion of indications to include intervertebral disc space is supported by robust prior analysis of bone grafting materials from posterolateral spine fusion studies, demonstrating that material composition differences do not raise different safety and effectiveness questions.