First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies

Inclusion Criteria: \[ Indication for performing a mid-face osteotomy using a transoral approach, and suitability for use of CARLO® system: \] 1. Surgical relocation of the maxilla is indicated, using a mid-face osteotomy via a transoral approach that can be performed using bilateral straight-cut lines (LeFort I). Patients for whom a concomitant re-positioning of the mandibula or other corrections are indicated may be included in the study, as long as these corrections do not affect the repositioning of the maxilla that is being assessed; these additional osteotomies will not be performed using the CARLO® system. \[ General requirements related to enrollment in a clinical study \] 2. Patient is willing and able to attend all scheduled visits and comply with all study procedures 3. Aged ≥18 4. Ability to understand and give study-specific informed consent 5. Written informed consent obtained from patient \[ General precondition for orthognathic surgery \] 6. Proven completion of the facial growth Exclusion Criteria: \[ General contraindications related to enrollment in a clinical study \] 1. Female patients who are pregnant or breast feeding or are planning to become pregnant during the study 2. Other patients who are vulnerable persons, such as adults lacking the capacity in the consent procedure, patients in emergency situations. 3. Known or suspected non-compliance, drug or uncontrolled alcohol abuse. 4. Presence of any condition or abnormality that in the opinion of the Investigator of the Investigator would compromise the safety of the patient or quality of the data 5. The patient is participating in, or intends to participate in another investigational drug or device clinical trial within 12 months after enrollment 6. Enrolment of the Investigator, his/her family members, employees and other dependent persons \[ General contraindications for orthognathic surgery \] 7. Missing indication for orthognathic surgery 8. Patients with bleeding diathesis or coagulopathy 9. Patients with increased perioperative airway risk factors due to anatomical structures which limits usage of endotracheal intubation 10. Patients with intolerance or hypersensitivity to local anesthetics 11. Patients with consumptive/malignant primary disease (e.g. renal failure, hepatic dysfunction, severe heart failure, etc.) and a life expectancy of \< 6 months 12. Patients that have an odontogenic osteomyelitis 13. Patients that have a diagnosed bone metabolism disorder e.g. Osteoporosis, Osteomalacia, Paget's disease, renal osteodystrophy, parathyroid disorders 14. Patients who have received or are receiving antiresorptive therapy (bisphosphonates). 15. Patient has previously undergone radiotherapy in the region of the intended osteotomy 16. Patients with impaired wound healing, for example due to Type II diabetes