Device Dossier

Suture Buttons - Soft-tissue anchor, non-bioabsorbable

Device Dossier for Suture Buttons - Soft-tissue anchor, non-bioabsorbable (Soft-tissue anchor, non-bioabsorbable, Class IIb, sponsor Revolution…

Intended purpose

For endoscopic surgery, the Suture Button, a non-bioabsorbable device designed to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include but is not limited to the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repair(minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

TGA Public Summary