Device Dossier

Delta Xtend CTA Heads - Humeral head prosthesis

Device Dossier for Delta Xtend CTA Heads - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor DePuy Synthes). ARTG record, intended…

Intended purpose

The Delta Xtend CTA Head is one component of the Delta Xtend Shoulder Prosthesis System and is intended for easy revision from reverse to hemi-arthroplasty in patients with non-functional rotator cuffs, and indicated for use in treatment of a grossly deficient rotator cuff joint with: • severe arthropathy and/or; • a previous failed joint replacement and/or; • fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory.

Functional description

The Delta Xtend CTA head is a specific hemi-head and is used when revision of a reverse shoulder is required due to glenoid loosening, or when glenoid bone stock is insufficient to fix a metaglene securely, the reverse shoulder can be converted to an hemi-prosthesis as a salvage procedure. The Delta Xtend CTA head is made out of cobalt chromium and is uncoated with a press fit fixation.

TGA Public Summary