Device Dossier

Sternal fixation system

Device Dossier for Sternal fixation system (Sternal fixation system, Class IIb, sponsor Zimmer Biomet). ARTG record, intended purpose, GMDN category —…

Intended purpose

To aid in the treatment of pectus excavatum and other sternal deformities by providing a means to stabilize the pectus bar implanted to reposition the bony structures (sternum, breastbone) by applying internal force outwards ontothe structures. The device should be removed with the pectus bar when remodelling is evident. "This GMDN code has been discussed and agreed with both TGA and the Manufacturer."

TGA Public Summary