Device Dossier

INTRAFIX™ Advance BIOCRYL RAPIDE™ Sheath and Screw - Fixation anchor, soft-tissue, biodegradable

Device Dossier for INTRAFIX™ Advance BIOCRYL RAPIDE™ Sheath and Screw - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue,…

Intended purpose

The DePuy Mitek INTRAFIX ADVANCE BIOCRYL RAPIDE Sheath and Screw System is indicated for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction.

Functional description

The INTRAFIX Advance Tibial Fixation System is an implant system used for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction. The two-part system consists of an absorbable expansion sheath and an absorbable tapered screw. The INTRAFIX Advance sheath and screw are made of Biocryl Rapide (BR) (15/85% by volume β- TCP/PLA PGA)

TGA Public Summary