Device Dossier

Axioma TT Glenoid Peg (Ti6Al4V) - Prosthesis, internal, joint, shoulder, glenoid component

Device Dossier for Axioma TT Glenoid Peg (Ti6Al4V) - Prosthesis, internal, joint, shoulder, glenoid component (Prosthesis, internal, joint, shoulder,…

Intended purpose

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: · non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; · inflammatory degenerative joint disease such as rheumatoid arthritis; · treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; · revision of a failed primary implant; · cuff tear arthropathy (CTA Heads only). The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.

Functional description

The SMR Axioma TT Glenoid Peg (Ti6AI4V) attaches to the uncemented Glenoid Baseplate TT (Ti6Al4V) (Axioma or L1 version) and together they are implanted into the glenoid capsule and hold the metal back liner that provides an articulation surface for the humeral head to articulate on.

TGA Public Summary