Device Dossier

SMR Reverse HP Glenosphere UHMWPE X-Lima + Ti6Al4V - Reverse shoulder prosthesis head

Device Dossier for SMR Reverse HP Glenosphere UHMWPE X-Lima + Ti6Al4V - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head, Class III,…

Intended purpose

The Reverse Glenosphere is part of the SMR Reverse Shoulder System and is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability. In cases with a deficient and unreconstructable rotator cuff, a hemiprosthesis with a CTA head or a Reverse Total Shoulder Arthroplasty is indicated.

Functional description

A reverse shoulder glenosphere is made of UHMWPE X-Lima + Ti6Al4V and is intended to be attached to the reverse shoulder base plate with a connector and screw and articulates with the reverse shoulder liner.

TGA Public Summary