US FDA Allow 510 (k) clearances to Polarisar's Stellar Knee

Polarisar, a Miami-based startup dedicated to developing a new class of Mixed Reality surgical technology, has announced that their Stellar Knee has received 510(k) clearance from the US Food and Drug Administration (FDA). Stellar Knee is the first report from Polarisar, a company focused on creating a new category of mixed reality surgical guidance. Polarisar and Stellar Knee create the intersection of physical surgery and virtual surgical guidance, creating a unique digital operating room. This digital OR environment uses mixed reality displays that provide the surgeon with real-time access to intraoperative anatomical information used to measure, plan and guide knee arthroplasty.

Using a unique combination of proprietary optical tracking algorithms and spatial computing software, Stellar Knee measures and captures clinically relevant hard and soft tissue anatomical information, enables submillimeter intraoperative planning, and provides precise resection accuracy and guidance. "This is an important moment for orthopedic surgery," said Dr. John Cooper, associate professor of orthopedic surgery at Columbia University Irving Medical Center. I was either dependent on the inaccuracy of traditional instruments or advanced technologies such as robotics to improve surgical precision. While these technologies provide important information that can be used to customize surgery for each patient, they require a large footprint in my OR and a significant financial commitment from my institution. Now I can use a low-profile digital assistant that makes real-time measurements and calculations that I can trust to confirm surgical decisions." Stellar Knee dynamically acquires patient-specific anatomical data and digitizes the data into holographic displays, with no room in the operating room except for a Mixed Reality headset that functions as a three-dimensional spatial computing tool.