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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Neosurgical Pty Ltd

Class:

Class III

Manufactured by:

Xiros Limited Also trading as Neoligaments a division of Xiros Springfield House Whitehouse Lane Yeadon, Leeds, LS197UE United Kingdom

Therapeutic area:

46242 - Surgical support tape, non-absorbable

Therapeutic indications:

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. 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

Authorization status:

A

Authorization date:

2021-12-08