Device Dossier

Synergen - Bone matrix implant, synthetic

Device Dossier for Synergen - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor More Group). ARTG record, intended…

Intended purpose

Synergen is intended for use to reconstruct bony voids or bone gaps in maxillofacial/oral applications. Synergen can be used with autograft as a bone graft extender.

Functional description

This product is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta‐Tricalcium Phosphate(ß‐TCP).The Synthetic Bone Substitute is progressively replaced by new bone according to the remodeling process. The total resorption of the product depends on numerous factors such as its size and volume, the location of the defect and surgical technique used.

TGA Public Summary