Device Dossier

Helysis PLDLA+β-TCP Interference Screw - Fixation screw, bone, biodegradable

Device Dossier for Helysis PLDLA+β-TCP Interference Screw - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor…

Intended purpose

The PLDLA+β-TCP interference screw is intended for soft tissue fixation to the bone.

Functional description

The bioabsorbable interference screw serves a dual purpose in tendon-to-bone fixation. It initially provide mechanical fixation by holding graft in place against bone. This "mechanical fixation" ensures that the graft remains in the correct position during the crucial early stages of healing when it's most vulnerable to stress and movement.

TGA Public Summary