Pixee wins FDA clearance for Knee+ NexSight surgical navigation

Date: 2025-04-22
Type: ARTICLE
Desk: Robotics
Topics: Augmented Reality, Knee Arthroplasty, Regulatory Clearance, Surgical Navigation
Deck: The wearable augmented-reality system guides knee implant positioning and targets U.S. outpatient surgery centres.
URL: https://korthosrobotics.com/research/pixee-knee-nexsight-fda-clearance-april-2025
Referenced profiles: Pixee Medical (https://korthosrobotics.com/ecosystem/company/pixee-medical)

Image: Pixee Medical
Pixee Medical has received FDA 510(k) clearance for Knee+ NexSight, an augmented-reality navigation system for total knee arthroplasty. Announced on 22 April 2025, the wearable solution is designed around U.S. ambulatory surgery centres, where surgical teams must fit guidance technology into compact operating rooms and repeatable outpatient workflows.
The system presents guidance to the surgeon during implant positioning, using a wearable interface to support alignment against the plan chosen for the patient. Pixee says it is compatible with primary knee implant systems and works without preoperative imaging. The surgeon performs the procedure while the system supplies navigation information within the operative workflow.
Knee+ NexSight builds on Pixee’s earlier Knee+ platform, which the company says had been used in more than 10,000 procedures across over 20 countries by the announcement date. Feedback from orthopaedic surgeons informed the new system’s development for high-throughput U.S. surgical settings. The compact equipment is intended to support adoption across outpatient centres and hospital practices.
An optional connectivity module adds secure exchange with third-party web services and delivery of software updates. This extends the product from intraoperative guidance into connected surgical workflows, with the navigation system remaining the core cleared application. Pixee’s official clearance release identifies implant compatibility, wearable guidance and connectivity as the principal elements of the new generation.