Device Dossier

BIO-VIM Bioabsorbable Ligament Anchor - Fixation anchor, soft-tissue, biodegradable

Device Dossier for BIO-VIM Bioabsorbable Ligament Anchor - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue, biodegradable,…

Intended purpose

Bioabsorbable arthroscopy implants intended to be anchored to the bone and to be used to reattach soft tissue such as ligaments, tendons, or joint capsules to the bone in orthopaedic surgical procedures in shoulder; used in either arthroscopic or open surgical procedures, to stabilise damaged soft tissue, in conjunction with appropriate post operative immobilisation throughout the healing period.

Functional description

Bioabsorbable suture anchor made of a material that can be chemically degraded and typically absorbed via natural body processes. Bio-Vim anchors are composed of Poly (L-Lactide-co-D, L-Lactide), with β tricalcium phosphate and non-bioabsorable suture. Anchors are fully threaded featuring single or dual threads to maximise cortical and cancellous fixation, have a covered saddle tip to protect the sutures and recannulated to channel growth actors, provided sterile, for single use only.

TGA Public Summary