Device Dossier

SMR Glenoid Plate - Reverse shoulder prosthesis base plate

Device Dossier for SMR Glenoid Plate - Reverse shoulder prosthesis base plate (Reverse shoulder prosthesis base plate, Class III, sponsor Enovis…

Intended purpose

The glenoid plate is intended for use only with 40 mm or 44 mm glenospheres in reverse shoulder arthroplasty. The glenoid plate is indicated for patients suffering from disability due to 1)severe glenoid bone loss in revision surgery of hemi, anatomic or reverse total shoulder arthroplasty 2)displastic glenoid, 3)treatment of glenoid fracture (plurifragmental glenoid fracture or intra-op glenoid fracture) 4)insufficient primary fixation of metal back glenoid

Functional description

A sterile metal plate used in for reverse shoulder procedures to provide a base for the fixation of the Glenoid Component and is attached firmly to the scapula with screws. It serves as the foundation for the reverse shoulder prothesis head (glenosphere).

TGA Public Summary