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Navbit Rapid Surgical Plan is intended for pre-operative planning for primary total hip arthroplasty. Rapid Surgical Plan is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty. Rapid Surgical Plan is indicated for individuals undergoing primary hip surgery.

The Navbit Rapid Surgical Plan is a non-invasive total hip arthroplasty planning software. It is software as a medical device (SaMD) which provides pre-operative planning for acetabular component orientation for orthopaedic surgeons. The software provides a recommended cup target intended to reduce impingement based on each patient's spinopelvic mobility. The ultimate decision to use the cup target recommended by Navbit is the surgeon's based on their clinical judgement.

For Lateral Patient Registration: The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position. The Navbit® Sprint System for lateral patient registration is indicated for use: - . in Hip Arthroplasty surgical procedures; - with acetabular cups that are uncemented and allow for post-impaction correction; . - when post-impaction confirmatory measurement checks can be obtained. For Supine Patient Registration: The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position. The Navbit® Sprint System for supine patient registration is indicated for use: - in Hip Arthroplasty surgical procedures; . - with acetabular cups that are uncemented and allow for post-impaction correction; . - . when post-impaction confirmatory measurement checks can be obtained.

The Navbit® Sprint System is a computer assisted surgical navigation system for use in hip arthroplasty procedures. The Navbit® Sprint System utilizes a palm-sized computer module containing sensors including rate gyroscopes and accelerometers to generate real time angular measurements (inclination and anteversion angles) used to guide acetabular cup implantation during orthopedic procedures. During hip arthroplasty procedures, the Navbit® Sprint System assists the surgeon in registering the pelvic coordinate system and determining the inclination angle and the anteversion angle of the introducer/impactor relative to the registered pelvic coordinate system. The device requires registration to be performed in one of two acceptable patient positions - supine and lateral, and alignment guidelines are provided for each. Any surgical approach that allows this registration to be performed is appropriate for use with the Navbit® Sprint. The Navbit® Sprint System is provided terminally sterilized, single-use disposable.