Key facts
- OrthAlign, Inc. received FDA 510(k) clearance for the Lantern ASC system.
- The Lantern ASC system is a handheld orthopedic navigation solution.
- The system aims to provide precision comparable to robotic systems at a lower cost and complexity.
OrthAlign, Inc., a company specializing in handheld orthopedic navigation, announced on June 3, 2026, that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lantern ASC system. The Lantern ASC system is designed to provide the precision of advanced technology, typically found in robotic surgical systems, but at a significantly reduced cost and complexity. This clearance allows OrthAlign to market and distribute the Lantern ASC system in the United States.