Device Dossier

LK-2 Polyester Fabric (Poly-Tape) - Surgical support tape, non-absorbable

Device Dossier for LK-2 Polyester Fabric (Poly-Tape) - Surgical support tape, non-absorbable (Surgical support tape, non-absorbable, Class III, sponsor…

Intended purpose

Device intended to be used for tissue approximation, including use in reconstructing damaged or torn ligaments, tendons or other soft tissues according to the surgeon’s own preferred technique, and at his/her discretion. Also supplied for soft tissue (tendon and ligaments) fixation to bone with a surgical button or staple during orthopedic reconstruction procedures. This device is not for use as a synthetic ligament where a non-synthetic graft source (allograft and autograft) is available

Functional description

A device that is a flat single thickness or tubular tape made in an open Mock-Leno weaving pattern, manufactured from Polyester, and designed for permanent implantation for approximating and reconstructing damaged or torn tendons, ligaments, and other soft tissues, and for soft tissue (tendon and ligaments) fixation to bone during orthopaedic reconstruction procedures. They may be implanted using standard open or arthroscopic surgical techniques, depending on the repair they are being used for.

TGA Public Summary