Device Dossier

i=FACTOR Putty - Bone matrix implant, artificial

Device Dossier for i=FACTOR Putty - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor Life Healthcare). ARTG record,…

Intended purpose

Intended 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. The i=FACTOR Putty product provides an osteoconductive bone substitute that is remodeled to new bone during the natural healing process.

Functional description

A natural form of sintered hydroxyapatite (anorganic bone mineral or ABM) containing P-15. P-15 is a 15 a.a polypeptide, a portion of Type-I collagen that serves as a biomimetic attachment site for bone cells. The hydrogel carrier forms a matrix that improves the handling characteristics and helps contain the graft at the surgical site. The ABM particles within the matrix are radiopaque and sized between 250 and 425 microns. The graft is remodelled into new bone during the healing process.

TGA Public Summary