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Smart SPACE Shoulder 3D Positioner Smart SPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Smart SPACE Shoulder Cubit Guidance Smart SPACE Shoulder Cubit Guidance consists of a patient-specific 3D mapper, single use instrumentation, and an intraoperative guidance software. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Smart SPACE Shoulder Planner software Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system. The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software. Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation. Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation. Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software which assists the user in planning reverse and anatomic total shoulder arthroplasty. In addition, a choice of intraoperative execution of the surgical plan using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder System (subject device) is compatible with Lima Corporate shoulder replacement implants; Verification testing was conducted utilizing those systems.

Smart SPACE Shoulder 3D Positioners Smart SPACE Shoulder System instrumentation consists of patient-specific 3D positioners. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Smart SPACE Shoulder Planner software Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software and 3D Positioners which assist the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using 3D positioners for glenoid K-wire placement and humeral head resection.

SmartSPACE Shoulder 3D Positioner SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. SmartSPACE Shoulder Planner software SmartSPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. SmartSPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system. The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the SmartSPACE Shoulder Planner software. SmartSPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation. SmartSPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation. SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

The SmartSPACE Shoulder System consists of the SmartSPACE Shoulder Planner software and a 3D positioner which assists the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using a 3D positioner for glenoid K-wire placement.