Device Dossier

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

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

Intended purpose

STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional 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 prepared from a copolymer of glycolide and ε-caprolactone. Device contains triclosan, a broad spectrum antibacterial agent, at no more that 2360ug/m. The barbed suture consists of two barb segments oriented in opposing directions, separated by an un-barbed transition zone. Each barb segment is armed with a surgical needle on the end. The device allows for tissue approximation without the need to tie surgical knots.

TGA Public Summary