Device Dossier
LARS - Posterior Cruciate - Ligament prosthesis, non-absorbable
Device Dossier for LARS - Posterior Cruciate - Ligament prosthesis, non-absorbable (Ligament prosthesis, non-absorbable, Class III, sponsor Device…
- GMDN category: Ligament prosthesis, non-absorbable
- Sponsor: Device Technologies
Intended purpose
A device intended for the reconstruction of the posterior cruciate ligament of the knee. LARS should not be the first preference for posterior cruciate ligament reconstruction. Use of LARS in PCL reconstruction is limited to situations where other graft tissue is not available or not acceptable. 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