Vitoss bone graft substitute - Bone matrix implant, artificial

Intended purpose

Intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure and for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Vitoss should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. It 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 placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Functional description

Device is a resorbable porous calcium phosphate bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Vitoss Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When it is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfacr