Device Dossier

Soft-tissue anchor, non-bioabsorbable

Device Dossier for Soft-tissue anchor, non-bioabsorbable (Soft-tissue anchor, non-bioabsorbable, Class IIb, sponsor Actis Medical). ARTG record, intended…

Intended purpose

The R3ACT™ Stabilization System is a fixation device comprised of a titanium alloy screw, UHMWPE suture, and a polyurethane component. The R3ACT™ is implanted as a rigid screw-type anchor and transitions to engage the internal UHMWPE suture loop and bumper to allow for dynamic diastatic motion and fibular rotation in a semi constrained fashion. It is offered in varying sizes to accommodate a variety of applications and variation in anatomy. The suture loop is non-absorbable. The R3ACT™ Stabilization System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with ankle fractures.

TGA Public Summary