Device Dossier

Tornier Simpliciti Nucleus - Coated shoulder humeral stem prosthesis

Device Dossier for Tornier Simpliciti Nucleus - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class III, sponsor…

Intended purpose

Intended for total and hemi-arthroplasty of the shoulder.

Functional description

The metaphyseal humeral component of a total shoulder or hemi-shoulder prosthesis. It is used as part of a system that also includes a metal humeral head and (for total shoulder) an ultrahigh molecular weight polyethylene glenoid component. It is made of titanium alloy with a sintered bead coating that allows for bone in-growth. It is intended for press-fit un-cemented use.

TGA Public Summary