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ßGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for use in the treatment of surgically created osseous defects or osseous defects caused by traumatic injury to the bone. ßGran Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. ßGran Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following implantation the calcium phosphate matrix will be resorbed and is replaced with bone during the healing process.

BGran is a porous, resorbable osteoconductive scaffold constructed of highly pure ß tri-calcium phosphate for use in the repair of bony defects. The material is designed and manufactured to achieve the specification set out in the standard ASTM F 1088-87 (1992) e-1. The interconnected pores provide a three-dimensional scaffold that mimics the geometry of human cancellous bone matrix. The three-dimensional platform provided by BGran's osteoconductive scaffold guides the regenerating bone throughout the defect into which it has been implanted. Pore diameters ranging from 1 pm to 700 m support re-vascularisation and cellular invasion throughout the matrix Studies have shown that when ß tri-calcium phosphate is implanted in direct contact with host bone, which has a viable blood supply, that it responds physiologically. Throughout the healing process the matrix resorbs and is replaced by bone and connective tissue. Complete resobption takes between 3 to 12 months BGran is supplied as granules, available in three sieve sizes, sterile for single patient use