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The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS System proposed in this submission is a modification of the ExactechGPS System cleared per 510(k) #K213877. The ExactechGPS System is an image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals. The ExactechGPS System works with ExactechGPS hardware trackers that communicate intraoperative data to the ExactechGPS hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery. The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology.

The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the requred anatomical landmarks can be identified on the patient's preoperative CT scan. The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application. The ExactechGPS Total Ankle Navigation is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.

The ExactechGPS Total Ankle Application proposed by Blue Ortho in this submission is new clinical software application. The ExactechGPS Total Ankle Application (TAA) system is intended to be used during stereotaxic surqical procedures to aid the surgeons in locating anatomical structures and aligning the endoprosthesis with the patient bony anatomy provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan. The ExactechGPS Total Ankle Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the tibia and talar bones as part of a total ankle arthroplasty procedure. The ExactechGPS Total Ankle Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model. It encompasses two software applications: - The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application. - -The ExactechGPS Total Ankle Navigation Application is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures. The ExactechGPS Total Ankle Navigation is working on the Blue Ortho ExactechGPS System cleared per 510(k) #K213877. The system is composed of ExactechGPS Trackers, which are rigidly fixed to the patient bony anatomy, and other components (ExactechGPS Station and ExactechGPS camera) that are not in contact with the patient.

The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618. The ExactechGPS® System is an image-quided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS® System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals. The ExactechGPS® System works with ExactechGPS® hardware trackers that communicate intraoperative data to the ExactechGPS® hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery. The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.

The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan. The ExactechGPS Total Shoulder Planning Application is specifically indicated for pre-operative planning of Total Shoulder Arthroplasty using the Equinoxe system. The ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components. The Exacted GPS Total Shoulder Navigation is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

The ExactechGPS Total Shoulder Application proposed in this submission is a modification of the ExactechGPS Total Shoulder Application cleared per 510(k) #K173372. The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to quide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning. In the predicate device, the planning step was only indicated for pre-operative planning of the dlenoid part of the Equinoxe system. This submission proposes the addition of the humeral component. Therefore, the proposed ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components. The proposed ExactechGPS Total Shoulder Planning and Navigation Applications integrate some other modifications compared to the predicate device. These modifications are documented in Letter to Files. The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology. No changes to the hardware platform or system accessories are proposed by this submission.

The Exactech GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS System proposed in this submission is a modification of the ExactechGPS System cleared per 510(k) #K152764. The ExactechGPS System is an image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals. The ExactechGPS System works with ExactechGPS hardware trackers that communicate intraoperative data to the ExactechGPS hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery. The camera component that communicates with trackers is compliant with EN 62471 (Photobiological safety testing). The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology.

The ExactechGPS is intended for use during preoperative planning and during stereotaxic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan. The ExactechGPS Total Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

This submission proposes modifications to the ExactechGPS Total Shoulder Application cleared per #K162567. The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning. At initial release, the segmentation step was manually conducted by Blue Ortho. This submission proposes the addition of a semi-automatic segmentation option, where surgeons can elect to not send the CT exams to Blue Ortho for segmentation but employ a semiautomatic segmentation process to virtually reconstruct the bony anatomy of the patient in three dimensions. The use of semi-automatic segmentation to virtually recreate patient bone is available for planning only, and not for use during a navigated surgical procedure.

The ExactechGPS is intended for use during preoperative planning and during stereotaxic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan. The ExactechGPS Total Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

The ExactechGPS Total Shoulder Application is a modification of the Exactech GPS stereotactic navigation system designed to help guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. Like predicate Exactech GPS system software dedicated to use with total knee arthroplasty procedures, the ExactechGPS Total Shoulder Application works with Exactech GPS hardware trackers that communicate intraoperative data to the Exactech GPS hardware station to provide surgeons with real-time information on the position of patient anatomical structures and of instrumentation used to prepare patient bone during stereotaxic surgery. The ExactechGPS Total Shoulder Application adds a preoperative planning feature, where surgeons use CT-scan images of patient bone with software models of Exactech Equinoxe implants to preoperatively plan procedures in a virtual environment prior to surgery. The ExactechGPS Total Shoulder Application is used with the same ExactechGPS V2 station, trackers, and disposable kit hardware as the predicate ExactechGPS. This submission includes new surgical instruments dedicated to total shoulder arthroplasty.

The EXACTECH GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for primary and revision Total Knee Arthroplasty.

The EXACTECH GPS is an Image Guided Surgery, or Navigation, system for orthopedic surgical procedures intended to be used to intraoperatively assist surgeons during total knee arthroplasty. The EXACTECH GPS enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.

The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to help surgeons locate anatomical structures and align endoprostheses. It is specifically indicated for Total Knee Arthroplasty.

The BLUE NAVIGATION SYSTEM is an image guided, or navigation, system for orthopedic surgical procedures. It is intended to intraoperatively compute and display information such as distances and angles related to surgical instrument position. It provides this data to help surgeons make decisions, and is not intended to make surgical decisions or replace surgical actions. The station is composed of an optical localizer system, a computer, and a screen. The localizer tracks in real time the positions of trackers rigidly attached to patient bone or surgical instruments. The BLUE NAVIGATION SYSTEM is imageless, meaning there is no need for preoperative images (CR or MRI), but is based on intraoperative patient anatomical landmarks that are digitized at the beginning of the procedure by the surgeon. The station uses these landmarks to compute useful information that is displayed on a screen to help surgeons position prosthetic components.