Device Dossier

Osteoset Pellets - Bone matrix implant, artificial

Device Dossier for Osteoset Pellets - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor Stryker). ARTG record, intended…

Intended purpose

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

Functional description

Medical grade calcium sulfate pellets supplied in glass vials that are gently packed into open bone voids/gaps as a filler. The pellets prevent the ingrowth of soft tissue into the bone defect and are resorbed and replaced with bone during the healing process.

TGA Public Summary