Device Dossier

OSTEOSET XR Pellets Bone Graft Substitute - Bone matrix implant, artificial

Device Dossier for OSTEOSET XR Pellets Bone Graft Substitute - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor…

Intended purpose

For use as a bone void filler to be gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structures of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

Functional description

Preformed calcium sulfate / calcium phosphate pellets provided in glass vials that are gently packed into open bone voids/gaps. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

TGA Public Summary