DESCRIPTION
These instructions are intended for the Operating Surgeon and supporting Healthcare Professionals. The US instructions are intended for users in the United States and its territories. Rx only ADS Titanium Implants are comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient’s anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained ADS engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient’s anatomy to ensure that its dimensional properties allow an adequate fit. Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).