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The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

As the equivalent TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK consists of the following major components and subsystems: - The Station (Surgetics or NanoStation), consisting of a mobile computer system and an optical localizer - . Ancillary instruments, a specific motorized cutting block and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software application with iBlock option . The main modification to the predicate device K081232 concerns the modification of the motorized cutting block PRAXITELES®.

The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

As the equivalent TOTAL KNEE SURGETICS NAVIGATION SYSTEM, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES consists of the following major components and subsystems: - The Station (Surgetics or NanoStation), consisting of a mobile computer . system and an optical localizer - Ancillary instruments, specific motorized cutting block and reflective . markers used for reference and registration - TOTAL KNEE SURGETICS with Praxiteles software ● The main modification to the predicate device K060282 concerns the use of a new motorized cutting block PRAXITELES®.

The TOTAL HIP SURGETICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the pelvis, the femur can be identified by acquiring multiple landmarks. Example procedures include but are not limited to: Hip arthroplasty

As the equivalent TOTAL KNEE SURGETICS navigation system, the TOTAL HIP SURGETICS navigation system consists of the following major components and subsystems: - The Navigation Station, consisting of a mobile computer system and an . optical localizer - . Ancillary instruments and reflective markers used for reference and registration - . TOTAL HIP SURGETICS software

The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure. Example procedures include but are not limited to: Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column. Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.

The CTLOGICS Navigation System consists of the following major components and subsystems: - The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer - Ancillary instruments and reflective markers used for reference and . registration - . CTLOGICS Software

The UNI KNEE SURGETICS Navigation System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : - UniKnee Arthroplasty .

As the equivalent Surgetics ORTHO KNEELOGICS Navigation System and TOTAL KNEE SURGETICS Navigation System, the UNI KNEE SURGETICS navigation System consists of the following major components and subsystems: - The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer - Ancillary instruments and reflective markers used for reference and . registration - UNI KNEE SURGETICS software . The main modifications to the predicate devices concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.

The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures. Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

The Surgetics ORTHO OSTEOLOGICS Navigation System consists of the following major components and subsystems: - The Surgetics Station, consisting of a mobile computer system and an optical . localizer - Ancillary instruments and reflective markers used for reference and . calibration. - HTO Monitoring Software for, but not limited to open and closed wedge . osteotomy for the lower limb

The TOTAL KNEE SURGETICS NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : . Total Knee Arthroplasty

As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM consists of the following major components and subsystems: - The Surgetics Station, consisting of a mobile computer system and an . optical localizer - . Ancillary instruments and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software . The main modifications to the predicate device concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.

The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during: - Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model - Total Knee Arthroplasty with ZIMMER NEXGEN implant - UniKnee Arthroplasty with BIOMET OXFORD Phase III implant

The Surgetics ORTHO KNEELOGICS Navigation System (ORTHO KNEELOGICS) consists of the following major components and subsystems: - The Surgetics Station, consisting of a mobile computer system and an optical localizer - Ancillary instruments and reflective markers used for reference and registration - ORTHO KNEELOGICS Navigation applications software

CADImplant is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

The CADImplant software is specifically designed for use in dental implant procedures. It allows the dentist to locate dental implants on three planes (axial, sagittal and frontal) on a pre-treatment CT scan in real-time. Additionally, the software allows for the patient's prosthetic template to be pre-drilled according to the planning.

The Surgetics ENTact Endonasal Navigation System is intended for use as an aid to the surgeon for precisely locating anatomical structures either during open or percutaneous ENT/endonasal or sinus procedures.

The Surgetics ENTact Endonasal Navigation System is specifically designed for use in ENT/endonasal and sinus procedures. It allows the surgeon to locate surgical instruments (e.g., aspirator) on three planes (axial, frontal) on a preoperative CT scan in real-time. The system uses an infrared camera for localization and guidance of the surgical instrument. Additionally, a surgical planning capability using the Consultics Station is provided which allows the surgeon to pre-operatively plan the surgery.