Device Dossier

STRATAFIX™ Spiral PDS™ Plus Bidirectional - Barbed polyester suture, antimicrobial

Device Dossier for STRATAFIX™ Spiral PDS™ Plus Bidirectional - Barbed polyester suture, antimicrobial (Barbed polyester suture, antimicrobial, Class III,…

Intended purpose

Indicated for use in soft tissue approximation where the use of an absorbable suture is appropriate

Functional description

A monofilament, synthetic absorbable device composed of dyed (violet) polyester, poly(pdioxanone) containing triclosan (≤2360??g/m), a broad spectrum antibacterial agent. It consists of two barb segments with barbs oriented in opposing directions to allow tissue approximation without the need to tie surgical knots. Each barb segment is armed with a surgical needle on the end.

TGA Public Summary