Device Dossier

i-Thread Sterile Single Use Absorbable Polydioxanone Suture with Needle - Suture, polydioxanone

Device Dossier for i-Thread Sterile Single Use Absorbable Polydioxanone Suture with Needle - Suture, polydioxanone (Suture, polydioxanone, Class III,…

Intended purpose

Intended to fixate sub dermal tissue in an elevated position in plastic and reconstructive surgery.

Functional description

Consists of a needle, a needle cap, a hub, a sponge and polydioxanone (PDO) suture. Contacts the subcutaneous tissue of the human body to fix the subcutaneous tissue in an elevated position. Strength is 65% after 4 weeks of original strength, and it takes 180 to 240 days for complete .

TGA Public Summary