Polaris AR's Innovative Stellar Knee Achieves FDA Clearance

4 November 2023

POLARISAR is thrilled to announce a significant achievement: the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for their pioneering STELLAR Knee system. This clearance represents a major milestone for POLARISAR, a company committed to redefining surgical guidance within the realm of Mixed Reality.

STELLAR Knee is the vanguard of POLARISAR's vision, bridging the gap between physical surgery and virtual surgical guidance. It establishes a unique digital operating room environment where Mixed Reality displays provide surgeons with real-time access to vital intraoperative anatomical data. This data is instrumental in the measurement, planning, and guidance of Total Knee Arthroplasty procedures.

STELLAR Knee's achievement is attributed to its proprietary optical tracking algorithms and spatial computing software. It excels in capturing clinically significant hard and soft tissue anatomical data, enabling sub-millimetric intraoperative planning, as well as precise resection accuracy and guidance.

An exceptional feature of STELLAR Knee is its unobtrusive presence in the operating room. It relies on a Mixed Reality headset, functioning as a 3-dimensional spatial computing tool, to seamlessly acquire patient-specific anatomical data and render it as holographic displays. This fosters a real-time digital data exchange between the surgeon and the technology, empowering surgeons to make informed clinical decisions. The highly customizable and intuitive user interface allows surgeons to perform swift assessments and make precise adjustments to their surgical plans.

STELLAR Knee offers streamlined integration, cost-efficiency compared to traditional surgical guidance systems, and the potential to elevate the standard of care. Notably, the STELLAR Knee workflow is compatible with all total knee replacement implant systems, ensuring its broad applicability.

POLARISAR and STELLAR Knee are at the forefront of creating a novel category in surgical guidance software, harnessing the latest visual display technology. Beyond benefiting surgeons and patients, this groundbreaking solution empowers healthcare providers to raise the bar for knee arthroplasty care.

Source: prnewswire.com