INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW 

DESCRIPTION

The INION HEXALON™ is an interference screw intended to allow secure fixation and maintain the stability of bone-tendon-bone or soft tissue grafts in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist in conjunction with appropriate immobilization.

The INION HEXALON™ is made of degradable co-polymers composed of L-lactic acid, D-lactic acid and trimethylene carbonate. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The coloured screws are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures. The INION HEXALON™ gradually loses strength during 18-36 weeks. Bioresorption takes place within two to four years.

The INION HEXALON™ is offered in different sizes and is cannulated allowing the screw to be inserted over a guide wire. The screw is designed to be used with customized Inion® instrumentation.

The INION HEXALON™ is sterile and non-collagenous.

INDICATIONS

The INION HEXALON™ is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

CONTRAINDICATIONS

The INION HEXALON™ is contraindicated in case of:

• Insufficient quality or quantity of bone for interference screw attachment.

• Active or potential infections.

• Patient conditions including limited blood supply, chronic disease which causes insufficient quality of bone, and where patient co-operation cannot be guaranteed (e.g. alcoholism, drug abuse).