Device Dossier

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device - Barbed polyester suture, antimicrobial

Device Dossier for STRATAFIX Spiral PDS Plus Knotless Tissue Control Device - Barbed polyester suture, antimicrobial (Barbed polyester suture,…

Intended purpose

“The STRATAFIX™ Spiral PDS™ Plus Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate”.

Functional description

An antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(pdioxanone). Device contains triclosan, a broad spectrum antibacterial agent, at no more that 2360ug/m.The suture consists of unidirectional barbed suture material, armed with a surgical needle on one end, a closed fixation loop at the other end to anchored the suture. Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

TGA Public Summary