Device Dossier

NovaBone Putty Syringe Delivery - Bone matrix implant, synthetic

Device Dossier for NovaBone Putty Syringe Delivery - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Emergo). ARTG…

Intended purpose

A bioactive synthetic bone matrix implant intended to be packed into bony voids or gaps of the skeletal system 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. The device provides a bone filler that resorbs and is replaced with bone during the healing process.

Functional description

The device is an osteoconductive bioactive device used for grafting osseous defects. It is a pre-mixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder and composed solely of elements that exist naturally in normal bone. A series of surface reactions results in the formation of a calcium phosphate layer on the particles which provides scaffolding onto which new bone will grow allowing complete repair of the defect.

TGA Public Summary