Device Dossier

Cranofacial fixation plate, non-biodegradable

Device Dossier for Cranofacial fixation plate, non-biodegradable (Cranofacial fixation plate, non-biodegradable, Class IIb, sponsor Zimmer Biomet). ARTG…

Intended purpose

A small, implantable sheet of firm material that is attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

TGA Public Summary