OrthAlign Receives FDA 510(k) Clearance for Lantern ASC Navigation System for Ambulatory Surgery Centers

Irvine, CA-based OrthAlign has announced FDA 510(k) clearance for the Lantern ASC system, a handheld orthopedic navigation solution designed for ambulatory surgery centers. The system pairs a reusable navigation unit with a procedural Smart Pack Kit to deliver accurate, real-time navigation for total knee, partial knee, and gap balancing procedures in both primary and revision cases.

Based on the success of over 450,000 OrthAlign procedures, the Lantern ASC system is designed to integrate seamlessly with existing Lantern instrumentation and is compatible with most implant systems.

While robotic systems require significant upfront investment, lengthy setup times, and steep learning curves in the operating room, OrthAlign said Lantern ASC removes those barriers. The portable and scalable solution was built for the realities of the ASC environment, where ambulatory surgery centers have emerged as the fastest-growing segment in orthopedics. The company positions Lantern ASC as an accurate, simple, and cost-effective technology that provides the precision of advanced navigation at a fraction of the cost and complexity of robotic systems.

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