POLARIS^AR has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its STELLAR knee. STELLAR knee is the first FDA clearance for the company, which is focused on creating a new category in mixed reality surgical guidance.
 
The company and STELLAR knee aim to build the intersection of physical surgery and virtual surgical guidance for a novel digital operating room environment. The environment uses mixed reality displays to provide real-time access to intraoperative anatomic data used to measure, plan, and guide total knee arthroplasty (TKA) procedures.
 
STELLAR knee blends POLARIS^AR proprietary optical tracking algorithms and spatial computing software to measure and capture clinically meaningful hard and soft tissue anatomic data. It also enables sub-millimetric intraoperative planning and precise resection accuracy and guidance.
 
The technology has no OR footprint besides a mixed reality headset, which acts as a 3D spatial computing tool. It dynamically acquires the patient-specific anatomic data and digitizes the info into holographic displays. By capturing the surgeon’s field of view, it creates real-time digital data exchange between the surgeon and tech to inform clinical decisions. Surgeons have full interactive capabilities with the user interface so they can make quick assessments and micro-adjustments to the surgical plan.
 
The company said the STELLAR knee can be used across all total knee replacement implant systems.
 
“One of the most important aspects of new technology entering the operating room is the impact it makes and footprint it requires,” Dr. Francis Gonzales, Professor of Orthopedic Surgery, University of California, San Diego told the press. “Technological advancements don’t always correlate with improvements within the OR. STELLAR Knee is an exception. With no footprint outside of the headset, no computers, or stalls, it does the thing it was designed to do brilliantly well—empower me to focus on what matters most, the surgery, and to be confident in the decisions I make.”
 
“Our software has the capacity to usher in the next generation of surgical advancements,” added POLARIS^AR CEO Paul Mikus. “This is a new day for orthopedics, and surgery as a whole, because the promise of Augmented Reality is now being fulfilled. STELLAR Knee is pioneering a new class of surgical software that utilizes best in class spatial computing and optimizes operating room workflow. STELLAR Knee not only impacts the surgeon and the patient, but also empowers healthcare providers to change the standard of care.”