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The Kelyniam Customized Craniofacial Implant (CCI) is intended to correct bony voids in the Craniofacial skeleton.

The implant is composed of Invibio Polyether Ether Ketone (PEEK-OPTIMA®) and fabricated using the patient's computed tomography (CT) imaging data. The device is provided non-sterile for steam sterilization prior to implantation and is attached to the native bone with commercially available FDA approved cranioplasty fixation systems. The Kelyniam Customized Craniofacial Implant (CCI) is a single use, non-load bearing device which is not intended to support any endosseous dental implants nor be used in areas where their intended use may be compromised in a subsequent surgery in the ora!-maxillofacial area. The implants will range in size from 50mm X 50mm X 150mm, and the thickness of the implant ranging from 2mm - 4mm with the nominal thickness of 3mm. The sizes and shapes of this implant may vary depending on the patients specific defect area. The implant will attach to native bone using commercially-available cranioplasty fasteners. The Customized Craniofacial Implant (CCI) is used to correct bony voids of the craniofacial region to include the zygoma, orbital rim, and adjacent bone. The Customized Craniofacial Implant (CCI) will not be used on any of the Maxilla bones that will affect the placement of current or future oralmaxillofacial implants, including endosseous dental implants. Also, the CCI Implant is not for use in the skeletal structures in the maxillofacial and/or oral regions.