Miami-based PolarisAR has received US FDA 510(k) clearance for STELLAR Knee, the Mixed Reality surgical guidance for total knee arthroplasty.

PolarisAR and STELLAR Knee are building the intersection of physical surgery and virtual surgical guidance to create a unique digital operating room environment. This digital OR environment utilizes Mixed Reality displays to provide surgeons with real time access to intraoperative anatomic data used to measure, plan, and guide Total Knee Arthroplasty procedures. Using a unique blend of proprietary optical tracking algorithms and spatial computing software, STELLAR Knee measures and captures clinically meaningful hard and soft tissue anatomic data, enables sub-millimetric intraoperative planning, and provides precise resection accuracy and guidance.

With no operating room footprint other than a Mixed Reality headset that acts as a 3-dimensional spatial computing tool, STELLAR Knee dynamically acquires patient specific anatomic data, digitizing that information into holographic displays. By capturing the surgeon’s field of view, STELLAR Knee creates a real-time digital data exchange between the surgeon and the technology that informs clinical decisions. Surgeons have full interactive capabilities with the highly customizable and intuitive user interface, enabling them to make quick assessments and micro-adjustments to the surgical plan.

With minimal physical setup, an easy integration process, and competitive pricing compared to traditional surgical guidance systems, STELLAR Knee has the ability to shift the standard of care. The STELLAR Knee workflow is open and available to be utilized across all total knee replacement implant systems. POLARISAR and STELLAR Knee are creating a new category in surgical guidance software utilizing the latest visual display technology.

“Our software has the capacity to usher in the next generation of surgical advancements,” said Paul Mikus, Chief Executive Officer of PolarisAR. “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.”

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