Device Dossier

Ligament prosthesis, non-absorbable

Device Dossier for Ligament prosthesis, non-absorbable (Ligament prosthesis, non-absorbable, Class IIb, sponsor Integrant). ARTG record, intended…

Intended purpose

The Integrant Tightrope is a double lift loop designed for use in fracture fixation. It doesn't not require knotting during surgery due to the self locking mechanism. The device is made from non-absorbable suture fibre-wires between two titanium buttons as well as a titanium insertion pin. It is designed to produce minimal irritation and can remain in patient for extended periods of time. The design allows shorter surgery times with improved fixation strength compared to previous techniques The device is designed as a fixation alternative to titanium screws for repairing syndesmosis injuries in the ankle but can also be used in other areas such as clavicular/coracoid fixation

TGA Public Summary