Device Dossier

BIOTWIN - Fixation screw, bone, biodegradable

Device Dossier for BIOTWIN - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor Compliance Management…

Intended purpose

The composite interference screw is intended to be used in knee ligament reconstruction procedures. It ensures the fixation of the transplant within the bone tunnel during the healing period and for a maximum duration of 48 months.

Functional description

The composite interference screw is a fixation system designed to ensure fixation of a transplant within a bone tunnel as part of a knee ligament reconstruction procedure. It is available in different diameters and lengths thus allowing the adjustment of the size of the screw to the size of the bone tunnel and therefore an optimal fixation of the transplant.

TGA Public Summary