Pixee’s Knee NexSight for Augmented Reality-Based Surgical Navigation Cleared by FDA

Pixee Medical’s latest innovation, Knee⁺ NexSight, has been cleared by the FDA. This is a next-gen augmented reality (AR) system designed to assist surgeons during total knee arthroplasty (TKA).

Headquartered in Besançon, France, Pixee specializes in AR-based navigation systems for orthopedic surgery.

Knee⁺ NexSight aims to deliver implant positioning accuracy without the infrastructure burden of conventional robotic systems. It meets the unique demands of the growing ambulatory surgical center (ASC) market in the US.

The platform builds on a track record of over 10,000 AR-assisted orthopedic procedures performed worldwide.

Developed with guidance from US-based surgeons, the system functions as a wearable surgical navigation tool. It delivers digital guidance directly into the surgeon’s field of view during TKA.

Using real-time bone landmark mapping, the platform allows for precise alignment of knee implants without requiring preoperative CT or MRI scans.

In clinical use, the system achieved a 94.2% success rate in restoring the lower limb’s mechanical axis within three degrees of the surgical target, with 96% of cases showing less than a one-degree difference between planned and actual implant angles.

Designed for outpatient efficiency, the system features a simplified three-step setup and avoids intraoperative calibration or percutaneous pins. This streamlined workflow could suit high-throughput settings like ASCs, where time and procedural consistency are critical.

Knee⁺ NexSight is compatible with all primary total knee implants. It eliminates the need for physical disposables, contributing to reduced waste generation during surgery. An optional connectivity module also supports secure integration with third-party digital systems, allowing future-ready upgrades and potential workflow enhancements.

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Knee⁺ NexSight Joins a Competitive AR Surgery Landscape

Knee⁺ NexSight enters a market where other FDA-cleared AR-based systems have already gained traction.

Robotic-assisted surgery has demonstrated benefits such as reduced blood loss and shorter hospital stays. However, its higher costs and equipment complexity continue to drive interest in more accessible solutions like AR-guided systems for outpatient procedures.

PolarisAR’s STELLAR Knee platform — a recent Edison Awards finalist — delivers mixed-reality guidance for TKA via a wearable headset and surgeon-controlled holograms. ImmersiveTouch’s ImmersiveAR system, cleared last year, supports complex surgeries by projecting patient-specific 3D anatomy directly onto the operative field for real-time decision-making.

In addition, Augmedics has performed over 10,000 AR-assisted spine procedures using its xvision Spine system. This marks a significant milestone in orthopedic AR adoption.

Levita Magnetics is combining AR headsets with robotic platforms for abdominal surgery. Meanwhile, Northwestern Medicine is applying AR to enhance intraoperative visualization in complex spinal cases.

The global market for surgical navigation systems — including AR, robotic, and computer-assisted platforms — is projected to surpass $35 billion by 2035. This growth reflects sustained investment in digital precision tools. Within that, AR in healthcare is expected to grow at a 36% annual rate through 2033, driven by its potential to improve surgical accuracy and patient safety.

With the clearance of Knee⁺ NexSight, the company continues its expansion in digital surgical solutions. It also plans to support evolving care models in joint replacement procedures.

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