Device Dossier

• BIO-VIM LRP Bioabsorbable Ligament Anchor with Fiber/Fiber Tape without needle (Knotless) (Two-piece Anchor) - Fixation anchor, soft-tissue, biodegradable

Device Dossier for • BIO-VIM LRP Bioabsorbable Ligament Anchor with Fiber/Fiber Tape without needle (Knotless) (Two-piece Anchor) - Fixation anchor,…

Intended purpose

These devices are intended to reattach soft tissue to bone in orthopaedic surgical procedures in Shoulder. These devices may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization 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 ß-tricalcium phosphate and non-bioabsorable suture.Anchors are fully threaded featuring single or dual threads to maximise cortical and cancellous fixation, having separate eyelet composed of "Titanium" or "PEEK (Poly-Ether-Ether-Ketone)" provided sterile, for single use only.

TGA Public Summary