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HEALOS® Bone Graft Material (“HEALOS”), combined with autogenous bone marrow, is intended for use in filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural healing process.

HEALOS® Bone Graft Material (HEALOS) is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of HEALOS are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight. The collagen is processed prior to mineralization using aqueous and organic purification steps to reduce lipids, salts, and endotoxins. Hydroxyapatite coats the surface of the collagen fibers by the controlled addition of calcium chloride, sodium phosphate, and sodium hydroxide. The mineralized collagen fibers are fixed into a three dimensional, open-cell matrix. HEALOS is provided as a sterile, dry material that must be hydrated with autogenous bone marrow at the point of use. HEALOS can be cut into shapes optimized for a specific population and is designed to retain its shape and physical integrity following specific population and is designed to simily resorbed during the natural process of bone formation and remodeling.