Device Dossier

LARS – Anterior Cruciate (DB) - Ligament prosthesis, non-absorbable

Device Dossier for LARS – Anterior Cruciate (DB) - Ligament prosthesis, non-absorbable (Ligament prosthesis, non-absorbable, Class III, sponsor Device…

Intended purpose

A device intended for reconstruction of the anterior cruciate ligament of the knee in situations where other graft tissue is not available or not acceptable. LARS should not be used for routine ACL reconstructions or reinforcement especially for patients who wish to be active and young patients. LARS devices are intended for use in patients with a mature and healthy bone structure to reconstruct soft tissues.

Functional description

Made from PET fabric roll LARS is a synthetic ligament designed to be used as a scaffold or to augment a soft tissue graft to mimic the normal anatomic ligament fibres. The device incorporates intra-articular fibres to resist fatigue and torsion and allow fibroblastic in-growth and encapsulation, as well as extra-articular fibres to provide strength and resistance to elongation. Traction threads are included to facilitate the positioning of the implant in its target site, these are not implanted

TGA Public Summary