INION TRINION™ BIODEGRADABLE MENISCUS SCREW

DESCRIPTION

The INION TRINION™ BIODEGRADABLE MENISCUS SCREW is intended to allow secure fixation of meniscal bucket-handle tears in conjunction with appropriate immobilization.

The INION TRINION™ BIODEGRADABLE MENISCUS SCREW is made of degradable co-polymers composed of L-lactic, D-lactic 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 TRINION™ BIODEGRADABLE MENISCUS SCREW maintains approximately 70% of its strength (in shear) at 9-12 weeks and gradually loses strength over 36 weeks with bioresorption estimated to occur within 3 years based on in vitro testing. In addition, based on in vitro biomechanical pull-out test, using an adult bovine medial menisci, the initial holding power of the INION TRINION™ BIODEGRADABLE MENISCUS SCREW is equal to that of a single vertical 2-0 polydioxanone suture, approximately 50 % of the initial holding power of the INION TRINION™ BIODEGRADABLE MENISCUS SCREW remains after 6 weeks and approximately 30 % after 12 weeks.

The INION TRINION™ BIODEGRADABLE MENISCUS SCREW has a dual-thread design with unthreaded middle section to allow optimal gap closure for promotion of healing. The screw is offered in different lengths and is cannulated allowing the screw to be needle guided. The screw is designed to be used with customized instrumentation, e.g. the INION TRINION™ CANNULAS, OBTURATOR and SCREW DRIVER.

The INION TRINION™ BIODEGRADABLE MENISCUS SCREW is sterile and non-collagenous.

INDICATIONS

The INION TRINION™ BIODEGRADABLE MENISCUS SCREW is indicated for the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

CONTRAINDICATIONS

The INION TRINION™ BIODEGRADABLE MENISCUS SCREW shoud not be used in flap or radial tears, in lesions that would not be considered for repair by suturing (e.g. in case of insufficient quality or quantity of meniscus), or in complex bucket-handle lesions such as double bucket-handle lesions. Other contraindications are active or potential infections, patient conditions including limited blood supply, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse).