Device Dossier

SMR Humeral Body Finned with Locking Screw (Ti6Al4V) - Shoulder humeral body prosthesis

Device Dossier for SMR Humeral Body Finned with Locking Screw (Ti6Al4V) - Shoulder humeral body prosthesis (Shoulder humeral body prosthesis, Class III,…

Intended purpose

The Humeral Body component is part of the SMR Anatomic Shoulder System which is intended for Partial, Total, Primary or Revision shoulder joint replacement in patients suffering from disability due to : non-inflammatory degenerative 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; and revision of a failed primary implant.

Functional description

The Humeral Body Finned with Locking Screw component is part of the SMR Shoulder System. It is used in the SMR anatomic combination. The finned external geometry is intended to give stability to the implant with respect to bone, in particular under torsion loads.

TGA Public Summary