i=FACTOR Flex FR - Bone matrix implant, synthetic

Intended purpose

i=FACTOR Flex FR is a bone graft substitute material for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). The bony voids may be surgically created defects or may result from traumatic injury to the bone.

Functional description

A natural form of hydroxyapatite (anorganic bone mineral or ABM) containing P-15. Comprised of ABM/P-15 particles in an inert biocompatible carrier, and freeze-dried to form flexible strips. P-15 is a 15 amino acid sequence polypeptide, a portion of Type-I collagen that serves as a biomimetic attachment site for bone cells. The bovine-derived ABM particles within the matrix are radiopaque and sized between 250 and 425 microns. Remodelled into new bone during the natural healing process.