DESCRIPTION

The INION FREEDOMPLATE™ biodegradable implants are 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. Bioresorption takes place within two to four years.

The INION FREEDOMPLATE™ implants are offered in different sizes and are designed to be used with customized instrumentation, e.g., the INION^® bone drill bits, threading taps, countersinks, drill guides, depth gauges, screw cutting pliers, screw driver, plate bending pliers and heating devices.

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

INDICATIONS

A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.

B. Specific indications: Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

CONTRAINDICATIONS

The INION FREEDOMPLATE™ 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 applications unless used in the presence of appropriate additional immobilization or fixation.

• Spinal indications.

• Mandibular tumor resection.

• Mandible unless used with appropriate maxillomandibular fixation.