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…
- GMDN category: Bone matrix implant, synthetic
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.