Device Dossier

Ascension® PyroTITAN Humeral Resurfacing Arthroplasty System PyroTITAN® Implant - Metaphyseal anchor-fixed humeral head prosthesis

Device Dossier for Ascension® PyroTITAN Humeral Resurfacing Arthroplasty System PyroTITAN® Implant - Metaphyseal anchor-fixed humeral head prosthesis…

Intended purpose

The Ascension® PyroTITAN ™ HRA System is intended for resurfacing of the humeral head due to non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and some cases of osteonecrosis), mild or moderate humeral head deformity and / or limited motion, post-traumatic arthritis, focal and large (Hill-Sachs) osteochondral defects, and patients with an intact or reparable rotator cuff.

Functional description

A semi constrained, monolithic device made entirely of PyroCarbon for resurfacing of the humeral head for non-cemented fixation. The inferior aspect has a tapered,cruciform projection that promotes enhanced overall and rotational stability on the humeral head. The use permits placement to minimize trauma and operating time, since intra-medullary reaming is not required. It only resurfaces the humeral head, saving valuable bone stock.

TGA Public Summary