Device Dossier

Humeral stem extension prosthesis

Device Dossier for Humeral stem extension prosthesis (Humeral stem extension prosthesis, Class IIb, sponsor Life Healthcare). ARTG record, intended…

Intended purpose

To be used in shoulder and elbow replacement surgery. Intended to be fixed to the proximal end of a humeral stem when there has been a large resection of the humerus due to trauma or a tumour to achieve the additional length required for connection to a humeral body in a shoulder replacement prosthesis. May also be used in the region of the distal humerus and proximal ulna in an elbow replacement prosthesis. Not intended to provide primary fixation. To be used to provide bone substitution or accommodate anatomical requirements of patients according to their individual requirements.

TGA Public Summary