INION OTPS™ MINI PLATING SYSTEM

DESCRIPTION

The INION OTPS™ MINI PLATING SYSTEM consists of fixation plates and screws 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 implants gradually lose their strength during 18-36 weeks in vivo. Bioresorption takes place within two to four years.

The INION OTPS™ biodegradable implants are offered in different sizes and are designed to be used with customized instrumentation, the INION^® bone drill bits, bone taps, countersinks, depth gauges, screwdrivers, plate bending pliers and heating devices.

The INION OTPS™ implants are sterile and non-collagenous.

INDICATIONS

These INION OTPS™ MINI PLATING SYSTEM implants are intended for use in fixation of non-comminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.

CONTRAINDICATIONS

These INION OTPS™ MINI PLATING SYSTEM implants are not intended for use in and are contraindicated for:

• Active or potential infection.

• Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse).

• Load bearing procedures.