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510(k) Data Aggregation
(446 days)
MyPAO SA patient-specific guides are devices intended to be used as anatomical guides. The guides are specifically designed based on the CT images of the patient (i.e., pelvis, proximal femur, distal femur). The guides are intended to assist the surgeon in the positioning of the acetabular fragment during periacetabular osteotomies to treat patients who require to undergo periacetabular osteotomy. MyPAO SA guides are intended for single use only.
The MyPAO SA guides are a set of patient specific 3D printed guides produced using patients' CT scans, intended to assist the surgeon in reaching the desired level of correction during periacetabular osteotomies.
The MyPAO SA guides represent a range extension as well as a simplified approach with respect to the already existing MyPAO guides cleared within K220706. The MyPAO SA guides, and their related preoperative and postoperative 3D printed bone models, are single-use surgical instruments provided non-sterile to the end-user.
The MyPAO SA Realignment System is composed of:
• One Preop SA guide used to mark the path of the planned line and to drill holes that facilitate placement and fixation of the Realignment SA Guide during the realignment phase.
• One Realignment SA Guide placed on the acetabular and iliac fragments after osteotomy, allowing for intraoperatively assessing the positioning of the acetabular bone fragment.
• 3D printed bone models of the preoperative and postoperative condition of the patient.
The MyPAO SA guides are available in two configurations, allowing to perform both right and left hip surgeries.
Given their design, the MyPao SA guides require a less invasive surgical access with respect to the predicates MyPao guides (K220706). On the other hand, the new MyPao SA guides are not indicated in case of reverse PAO corrections.
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