Device Dossier
Injectable Bone Substitute - Bone matrix implant, synthetic
Device Dossier for Injectable Bone Substitute - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Life Healthcare). ARTG…
- GMDN category: Bone matrix implant, synthetic
Intended purpose
The Injectable Bone Substitute is intended for use to reconstruct bony voids or bone gaps of the skeletal system (e.g. extremities, spine and pelvis).
Functional description
The performances of the Injectable Bone Substitute are the filling of bone defects and the bony ingrowth from local osseous tissue onto the surface of the product (osteoconduction process). The total resorption of the product depends on numerous factors such as its size and volume, the location of the defect, the surgical technique, the health status of the patient. The bone reconstruction time is always inferior to the total resorption time.