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The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures in the mid-face and maxilla of infant (from 29 days to 2 years of age) and child (greater than 2 years to 12 years of age) patients.

Specific indications:

• congenital anomalies correction in the orbital rim, orbital floor, maxilla and midface
• traumatic injuries.

The INION CPS™ 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures, and to maintain the relative position of bone grafts or bone graft substitutes, in orbital floor, medial and lateral orbital walls, orbital rim, mid-face, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) of child (greater than 2 years to 12 years of age), adolescent (greater than 12 years through 21 years of age) and adult patients. Specific indications: fixation of LeFort (I, II, III) osteotomies and mandibular orthognathic procedures

Inion CPS™ and Inion CPS™ Baby implants are bioabsorbable plates, screws and mesh plates made of bioabsorbable co-polymers. Inion CPS™ 1.5/2.0/2.5 System implants are composed of L-lactic acid, D-lactic acid and Trimethylenecarbonate. Inion CPS™ 1.5 Baby System implants are composed of L-lactic acid, D-lactic acid and Poly-Glygolic acid. 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 retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption of Inion CPS™ implants takes place within 2-4 years, and Inion CPS™ Baby implants within 2-3 years.

The systems consist of fixation plates, meshes and screws offered in different sizes and designed to be used with the Inion CPS™ bone drill bits, bone taps, self-drilling bone taps, countersinks, screw drivers, plate bending pliers and heating device. Nonsterile instruments are intended to be cleaned and sterilized before initial use and after each use.

The implants are provided sterile by gamma irradiation. They are intended for single use and shall not be re-sterilized or re-used. Implants are non-pyrogenic and fully synthetic. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented.

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