Pixee Medical Receives FDA Clearance for Knee+ NexSight
Pixee Medical has received FDA 510(k) clearance for its Knee+ NexSight system, a next-generation solution developed on a new augmented reality platform for total knee arthroplasty. The clearance enables the company to enter the United States market, with a focus on ambulatory surgical centres where procedural productivity and expense control are key considerations.
The Knee+ NexSight system has been developed for use within established surgical workflows. It is designed to integrate into existing clinical environments without requiring structural changes to standard operating procedures. The platform represents an update to earlier versions of the technology and is deployed on a more compact augmented reality system intended for use in operating theatre settings.
The system is compatible with surgical hoods and is configured to support routine clinical use. According to the company, the technology provides accuracy similar to robotic-assisted systems whilst avoiding the associated infrastructure and cost requirements. The instrumentation used with the system is described as less invasive and is associated with reduced blood loss. The system is designed to correspond to conventional surgical techniques without extending operative time.
Knee+ NexSight includes a virtual display positioned within the surgeon’s field of view. This enables access to intraoperative information without requiring a shift in visual focus from the surgical site. The system also includes voice control, enabling hands-free interaction during procedures. No disposable components are required for operation.
The development of the system forms part of Pixee Medical’s work in augmented reality applications for orthopaedic surgery. The company has focused on technologies that enhance implant placement accuracy while preserving compatibility with existing clinical practices. Knee+ NexSight works with a range of primary knee implants and supports personalised surgical approaches, including kinematic alignment.
Prior to receiving clearance in the United States, the system obtained CE mark approval in February 2026. Initial procedures using the technology were subsequently performed in Europe following this approval. These cases marked the early clinical use of the system outside of regulatory evaluation settings.
Pixee Medical has reported that its earlier generation of augmented reality products has been used in more than 10,000 procedures across over 20 countries. This level of usage indicates the adoption of augmented reality systems within orthopaedic surgical practice in multiple regions.
The FDA 510(k) clearance permits the commercial introduction of Knee+ NexSight in the United States. The company’s entry into this market aligns with the expansion of outpatient surgical services, chiefly within ambulatory surgical centres, where procedural effectiveness and resource management are prioritised.
Pixee Medical develops augmented reality systems for implant placement in orthopaedic surgery. Its technologies are intended to provide clinicians with tools designed to support operational accuracy and consistency. The company continues to expand its product portfolio in line with compliance clearances and clinical use in international markets.
