US-FDA grants 510(k) clearance to Polarisar Stellar Knee

Polarisar, a Miami based startup whose mission is to develop a new class of Mixed Reality surgical technology, announced that their Stellar Knee has received 510(k) clearance from the US Food and Drug Administration (FDA). Stellar Knee is the first clearance for Polarisar, a company focused on creating a new category in Mixed Reality surgical guidance.

Polarisar and Stellar Knee are building the intersection of physical surgery and virtual surgical guidance, bringing about a one-of-a-kind 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.

“This is an important moment for orthopaedic surgery,” stated Dr. John Cooper, Associate Professor of Orthopedic Surgery, Columbia University Irving Medical Center. "Prior to Stellar Knee, I was dependent on either the imprecision of conventional instrumentation, or complex technologies like robotics to improve surgical precision. These technologies, while delivering important data that can be used to personalize the operation for each patient, require a large footprint in my OR and a significant financial commitment from my institution. Now, I can wear a low-profile digital assistant that delivers real-time measurements and calculations I can trust, validating surgical decisions."

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 areal-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.

“One of the most important aspects of new technology entering the operating room is the impact it makes and footprint it requires,” stated Dr. Francis Gonzales, Professor of Orthopaedic Surgery, University of California, San Diego. “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,” 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.”

Polarisar is a Miami based startup whose mission is to develop a new class of Mixed Reality surgical technology. The company’s goal is to optimize intraoperative workflows and improve upon patient outcomes using advanced, 3-dimensional spatial computing algorithms – spanning beyond traditional navigation, patient specific instrumentation, robotics, and first-generation augmented reality.

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