Device Dossier

RSP Humeral Stem - Uncoated shoulder humeral stem prosthesis

Device Dossier for RSP Humeral Stem - Uncoated shoulder humeral stem prosthesis (Uncoated shoulder humeral stem prosthesis, Class III, sponsor Enovis…

Intended purpose

A component of a reverse shoulder prosthesis system indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

Functional description

A sterile component of a reverse shoulder prosthesis. It provides fixation within the proximal humerus and a site of attachment for the humeral socket shell, in which is contained a polyethylene insert that articulates with the reverse shoulder head. The stem is intended for cemented use.

TGA Public Summary