DESCRIPTION

The INION OTPS™ BIODEGRADABLE FIXATION SYSTEM consists of fixation plates* and screws 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 implants gradually loose 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

A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are generally intended for maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate plaster cast immobilization.

B. Specific indications:

• Fractures and osteotomies of the malleoli

• Ankle fractures

CONTRAINDICATIONS

These INION OTPS™ BIODEGRADABLE FIXATION 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).

• High-load bearing applications.

*Inion OTPS^TM Ankle Plates are not available for sale in the USA.