DESCRIPTION

The INION CPS^® BIOABSORBABLE FIXATION SYSTEM is a cranio-maxillofacial plating system intended to maintain accurate alignment of bone fractures and osteotomies in the cranium, mid-face and mandible (in conjunction with appropriate maxillomandibular fixation).

The INION CPS^® SYSTEM consists of fixation plates, meshes 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. INION CPS® SYSTEM implants retain minimum of 70 % of their initial strength 9 weeks after implantation. Bioresorption takes place within two to four years.

The INION CPS^® SYSTEM implants are offered in different sizes and are designed to be used with customized instrumentation, the INION CPS^® bone drill bits, bone taps, countersinks, screw drivers, plate bending pliers, and heating devices.

The INION CPS^® SYSTEM implants are sterile and non-collagenous.

INDICATIONS

A.       General indications: The INION CPS^® SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation).

B.       Specific indications:

• Fractures of the cranium, mid-face, maxilla and mandible

• Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)

• LeFort (I, II, III) osteotomies

• Pediatric reconstructive procedures

• Orthognathic or reconstructive procedures of the cranium, mid-face, maxilla or mandible

• Craniotomy flap fixation

CONTRAINDICATIONS

The INION CPS^® SYSTEM is not intended for use in and is contraindicated for mandibular tumor resection; 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). The system is not intended for use in the mandible without appropriate maxillomandibular fixation.