Device Dossier

STRATAFIX Spiral PGA-PCL Knotless Tissue Control Device Bidirectional - Suture, poliglecaprone

Device Dossier for STRATAFIX Spiral PGA-PCL Knotless Tissue Control Device Bidirectional - Suture, poliglecaprone (Suture, poliglecaprone, Class III,…

Intended purpose

STRATAFIX Spiral PGA-PCL (Poliglecaprone) Bidirectional Knotless Tissue Control Device is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Functional description

STRATAFIX Spiral PGA-PCL (Poliglecaprone) Knotless Tissue Control Device is an absorbable, bidirectional-barbed monofilament suture armed with a surgical needle on each end for tissue closure. The barbs are arrayed in opposing directions on either side of a transitional, nonbarbed segment. The device is advanced into the tissue, via surgical needles attached on each end, until opposing barbs are engaged. The barbs penetrate into surrounding tissue and secure the device in place.

TGA Public Summary