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The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as part of their treatment plan.

The X-Guide® Surgical Navigation System is an electro-optical dental implantation procedures by providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data. The X-Guide® Surgical Navigation System is currently cleared (K150222) with Bone Screws which are intended to affix an Edentulous Clin to an edentulous patients anatomy. The Edentulous clip is necessary to attach tracking patterns to facilitate the navigation and tracking process, and is calibrated to the patient anatomy and CT. As an alternative, the proposed EDX Bone Screws and EDX Nut may be used to secure tracking patterns to edentulous patient anatomy. The proposed EDX Bone Screws are a titanium screws which are tapered and vary in diameters of 2.7 mm and 3.2 mm wth thread lengths of 7mm and stud lengths of 4 mm, and 16 mm. In addition to the dimensional design changes, the screws have been modified with an M5 threading to accept the EDX Nut. The addition of M5 the Bone Screw is necessary to secure the tracking patterns to the patient. The 2.7 mm diameter EDX Bone Screws are typically placed to secure the EDX Tracker Arm. Should the bone be too soft resulting in a loose Bone Screw, a large diameter "rescue" EDX Bone Screw (3.2 mm diameter) can be placed. All of the EDX Bone Screws and EDX Bone Nuts are manufactured using a Ti6AL4V (Grade 5) alloy per ASTM F136 and adhere to the requirements of ASTM F543. The EDX Bone Screws are intended to be removed from the conclusion of the surgical implant procedure. The EDX Bone Screws are single use devices, sold in a non-sterile state and intended to be sterilized by the end user prior to use. The body of the proposed EDX Tracker Arms a stanless steel, which is a harder material providing more stability / rigidity in the Tracker Arm. A passivation coating is added to prevent oxidation of the during steam sterilization. The EDX Tracker Arms include a spike intended to added stability in EDX Tracker Arm registration. The body of the proposed EDX Tracker Arms are contoured in a variety of geometric shapes intended to minimize interferences with patient soft tissue by positioning on the Mandible and Maxilla in the posterior positions of the oral cavity. The EDX Tracker Arms are distributed in a non-sterile state, and intended to be sterilized by the end user prior to use.