Device Dossier

Cal-Cemex - Bone matrix implant, artificial

Device Dossier for Cal-Cemex - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor Compliance Management Solutions). ARTG…

Intended purpose

Calcemex bone void filler is intended for bony void or defects that are not intrinsic to the stability of the bony structure. The device is intended to be placed or injected into bony voids or gaps of the skeletal system. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that partially resorbs and is replaced with bone during the healing process. The device is not intended for use in the spine and should not be used in the presence of active or suspected infection.

Functional description

The device is a two-part (powder and liquid) polymethylmethacrylate/?-TCP bone void filler designed for mixing together at the point of use to form the filler. The device is intended to be placed or injected into bony voids or gaps of the skeletal system. The product provides a bone void filler that partially resorbs and is replaced with bone during the healing process. The device is not intended for use in the spine and should not be used in the presence of active or suspected infection.

TGA Public Summary