Device Dossier
Ligament prosthesis, non-absorbable
Device Dossier for Ligament prosthesis, non-absorbable (Ligament prosthesis, non-absorbable, Class IIb, sponsor Device Technologies). ARTG record,…
- GMDN category: Ligament prosthesis, non-absorbable
- Sponsor: Device Technologies
Intended purpose
Medical devices used in various orthopaedic procedures to replace or repair a missing or damaged ligamentous structure in order to restore natural function. In the context of Anterior Cruciate Ligament (ACL) repair, LARS should be utilised only after non-synthetic alternatives (allografts and autografts) have been considered as possible treatment options by the treating clinician and patient. LARS ACL repair should only be used in the presence of viable tissue remnants. In the absence of viable tissue remnants LARS should be used as an augmentation or reinforcement alongside an autograft or allograft. Regardless of treatment method, acute phase post ACL injuries should be treated with caution.