Device Dossier

Tornier Flex Shoulder System Reversed Insert - Reverse shoulder prosthesis

Device Dossier for Tornier Flex Shoulder System Reversed Insert - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor Stryker).…

Intended purpose

A component of the Tornier Flex Shoulder System intended for use as a replacement of shoulder joints in primary reverse, and a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The Tornier Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

Functional description

In combination with a reversed tray the insert is part of a reversed adapter. In conjunction with a humeral stem and reversed glenoid implants, the adapter is intended for replacement of the shoulder joint in a reversed configuration. Also for transformation of an anatomical prosthesis to a reversed configuration without the removal of the humeral stem during revision surgery. The insert is made from UHMWPE.

TGA Public Summary