Device Dossier

Injectable Bone Substitute - Bone matrix implant, synthetic

Device Dossier for Injectable Bone Substitute - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Medacta). ARTG record,…

Intended purpose

In'Oss is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. 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 created from traumatic injury to the bone. When packed into a bony site, In'Oss gradually resorbs and is replaced with bone during the healing process.

Functional description

In’Oss is a resorbable bone graft substitute. The non self-setting material is rapidly replaced by bone and provides mechanical resistance. It is composed of biphasic Calcium Phosphate granules associated with an excipient vehicle of a water-soluble gel which give the injectability properties. In’Oss is a putty form and adapts easily to the bony site, and allows biological fluid and cells diffusion leading to angiogenesis and osteogenesis both in surface and in the depth of the implanted area.

TGA Public Summary