Device Dossier

LUPINE™ BR ANCHOR W/ORTHOCORD™ - Fixation anchor, soft-tissue, biodegradable

Device Dossier for LUPINE™ BR ANCHOR W/ORTHOCORD™ - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue, biodegradable, Class III,…

Intended purpose

The LUPINE BR Anchor System is intended for soft tissue to bone reattachment. SHOULDER: Bankart Repair

Functional description

The Lupine BR Anchor is a Composite (PLGA/ TCP) absorbable suture anchor preloaded on a disposable inserter assembly intended to be implanted with in a pre-drilled bone hole to reconnect soft tissue to bone using a suture. This operative suture is provided without needles. The implant is supplied sterile ready to use. The anchors are available in single strand and dual strand (DS) configurations preloaded with one or two strands of #2 ORTHOCORD™ suture, respectively.

TGA Public Summary