Device Dossier

MectaGlass Injectable Putty - Graft, bone, synthetic

Device Dossier for MectaGlass Injectable Putty - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Medacta). ARTG record, intended…

Intended purpose

MectaGlass Injectable Putty is a synthetic, resorbable, biocompatible and bioactive substitute device, intended for the filling, reconstruction and / or fusion of bone defects or gaps of the skeletal system, in orthopedic surgery, spine, cranio-maxillofacial surgery and ENT. It is indicated in case of loss or lack of bone substance for bone defects of traumatic, pathological or surgical origin when autologous solutions are not applicable or sufficient in orthopedics, neurosurgery, cranio maxillo facial and otorhinolaryngology surgery in children and adult population: - Fusion or reconstruction of deformities and degenerative diseases in spine - Fusion or reconstruction of deformities and degenerative bone pathologies in orthopedic - Filling and reconstruction of bone defects due to resection of tumors, cyst or infection and in case of prosthetic revision - Filling after surgical bone defect (donor sites after removal of autograft, trepanation,…) - Filling after removal of cholesteatoma - Filling and reconstruction due to maxilla and periodontium pathologies (in adult only).

Functional description

MectaGlass Injectable Putty is a synthetic, resorbable, biocompatible and bioactive substitute device, composed of 45S5 bioactive glass granules (69%) mixed with a resorbable binder combining polyethylene glycol (12%) and glycerol (19%). It is intended for the filling, reconstruction and / or fusion of bone defects or gaps of the skeletal system, in orthopedic surgery, spine, cranio-maxillofacial surgery and ENT. MectaGlass Injectable Putty biomaterial is a non-hardening paste, ready to use.

TGA Public Summary