Search Results

Intellijoint VIEW is indicated to assist qualified healthcare professionals in preoperative planning and postoperative review of orthopedic surgery. The device allows for orthopedic implant to be overlaid on medical images for the purpose of selecting and positioning implants. The device includes tools for performing measurements and evaluating surgical treatment options. Clinical judgement and experience are required to properly use the software.

Intellijoint® VIEW is a web-based software as a medical device (SaMD) product that assists health care professionals complete preoperative planning and postoperative review for orthopedic surgery. Preoperative planning on Intellijoint® VIEW involves the user completing measurements on medical images to inform the selection and intraoperative positioning of orthopedic implant system components. Intellijoint® VIEW also allows for postoperative image review and measurement. Intellijoint® VIEW Templating tool allows the user to perform distance and angular measurements on scaled medical images, to inform selection of acetabular and femoral implant components. Intellijoint® VIEW Hip-Spine Assessment allows the user to assess a patient's spinopelvic relationship for preoperative functional acetabular cup position planning. The Application overlays acetabular measurement tools on standing and sitting lateral functional patient images to inform an appropriate implant position based on the functional relationship between the hips and spine.

The Intellijoint® Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The Intellijoint Navigation System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. Intellijoint HIP aids the surgeon in performing intra-operative measurements of limb position, joint center-of-rotation, and implant component positioning. Intellioint KNEE aids the surgeon in performing intra-operative measurements including alignmentation and bony cuts for implant component positioning. Example orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty - Revision Hip Arthroplasty - Total Knee Arthroplasty

The Intellijoint® Navigation System (IINS) is an imageless optical navigation system intended for use in orthopedic surgery. The IINS consists of an infrared Camera, Camera Drape, optical tracking Spheres, a computer Workstation and associated hardware. This submission provides the addition of Total Knee Arthroplasty (TKA) to the indications for use (cleared in K171525), allowing real-time measurements of varus/valgus angle, flexion/extension angle, and resection depth for distal femur and proximal tibia cuts during TKA procedures. The modifications include the addition of TKA-specific mechanical instruments and software. The updated product will be referred to as the Intellijoint® Navigation System throughout this submission.

The Intellijoint HIP Generation 2C System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors. The Intellijoint HIP Generation 2C System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Example orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty

The Intellijoint HIP® Generation 2C System is an imageless optical navigation system intended for use in orthopedic surgery. The device provides intra-operative assessment of patient leg length, offset, anterior-posterior change, hip center of rotation change, and acetabular cup angle during Total Hip Arthroplasty procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware. This submission describes updates implemented to provide terminally sterile bone screws to the user, which were previously only supplied non-sterile. The intended use and fundamental scientific technology is unchanged, and remains substantially equivalent to the predicate device.

The Intellijoint HIP Generation 2B System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The Intellijoint HIP Generation 2B System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. The surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Example orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty - Revision Hip Arthroplasty

The Intellijoint HIP® Generation 2B System is an imageless optical navigation system intended for use in orthopedic surgery. The device provides intra-operative assessment of patient leg length, offset, anterior-posterior change, hip center of rotation change, and acetabular cup angle during Total Hip Arthroplasty procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware. The Intellijoint HIP® Generation 2B System is an update to the Intellijoint HIP® System previously cleared in 510(k) K162364. This submission provides the addition of revision hip arthroplasty (RHA) procedures to the indications for use, and the use of either linear or non-linear acetabular cup impactors. Other minor modifications made to the device are also provided.

The Intellijoint HIP Generation 2A System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors. The Intellijoint HIP Generation 2A System is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, and implant component positioning. Example orthopaedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty

The intellijoint HIP® Generation 2A System is an imageless optical navigation system intended for use in orthopaedic surgery. The device provides intra-operative assessment of patient leg length, offset, and acetabular cup angle during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware. The intellijoint HIP® Generation 2A System is an update to the intellijoint HIP® System previously cleared in 510(k) K151364. The updates include revised software to support THA procedures performed using the Direct Anterior Approach, modified methods of patient registration, and leg position measurement.

Intellijoint HIP™ is a computer-controlled, optical localizer intended to provide intraoperative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors. Intellijoint HIP™ is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Example orthopaedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - - -Minimally Invasive Hip Arthroplasty

The intellijoint HIP™ System is an imageless optical navigation system intended for use in orthopaedic surgery. The device provides intra-operative assessment of patient leg length, offset, anterior-posterior change, hip center of rotation change, and acetabular cup angle during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware. This submission is an update to the intellijoint HIP™ System previously cleared in 510(k) K133759. The updates include an acetabular cup alignment feature, modifications to the method of patient registration, and other minor design and aesthetic improvements.

Intellijoint HIP™ is an infrared. computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implants, relative to anatomical structures and reference axes. Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies. Example orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty

The Intellijoint HIP™ System is an imageless optical navigation system intended for orthopedic surgery. The Intellijoint HIPTM System provides intra-operative assessment of patient leg length and offset during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared sensor, a tracked reflective marker assembly (beacon), a computer workstation, software, and bone fixation components. The infrared sensor is affixed to the patient's pelvis and the beacon is attached to the patient's femur. The system records the position and orientation of the femur relative to the pelvis prior to hip dislocations. This baseline information can then be used to track the change in leg length and leg offset during the joint replacement procedure.