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MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use. The MySpine S2-Alar/Alac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only.

The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identically to the other Medacta MySpine products, the MySpine S2-S1 Pedicle and Sacro-Iliac Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.