OrthAlign, Inc. Receives FDA 510(k) clearance for the Lantern® ASC system

IRVINE, Calif., June 3, 2026 /PRNewswire/ -- OrthAlign, Inc., the pioneer of handheld orthopedic navigation, today announced FDA 510(k) clearance for the Lantern ASC system, a solution that delivers the precision of advanced technology at a fraction of the cost and complexity of robotic systems. As ambulatory surgery centers (ASCs) emerge as the fastest-growing segment in orthopedics, Lantern ASC gives those centers a decisive competitive advantage: world-class outcomes without the significant capital burden or hidden implant volume commitments that robots demand.

While robotic systems require massive upfront investment, lengthy setup times, and steep learning curves in the operation room (OR), Lantern ASC removes those barriers entirely. Built for the realities of the ASC environment, Lantern ASC 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 in both primaries and revisions.  This portable, scalable, and immediately deployable solution was designed to integrate seamlessly with existing Lantern instrumentation and is compatible with most implant systems. Lantern ASC meets the needs of modern ASCs as an Accurate, Simple, and Cost-effective technology.

"As total joint arthroplasty shifts to the ASC and patients seek technology for their knee or hip replacements, surgeons and administrators need a smart solution, both clinically and economically," said Eric Timko, CEO of OrthAlign. "We engineered Lantern ASC to be a technology that leaves no stakeholder behind. Surgeons get accuracy and reliability, patients get the outcomes they came for, and the business gets a leading technology that works for the bottom line. Unlike technologies that burden a center's finances and throttle OR efficiency, Lantern ASC improves throughput, maintains or beats manual procedure times, and makes advanced navigation something that meets the needs of the entire ASC ecosystem."

"The orthopedic technology landscape has expanded significantly, and ASCs have more options than ever to bring advanced technology into their programs," said Michael Ast, MD, Chief Medical Innovation Officer and Director of ASC Strategy at Hospital for Special Surgery. "Lantern ASC stands out because it was designed with the ASC's specific operational and economic realities in mind. It delivers advanced, consistent technology without the capital burden, implant restrictions or workflow complexity that higher-infrastructure robots can carry. For centers focused on efficiency, throughput, and financial discipline, it is an exceptionally strong fit."

As ASCs continue capturing a larger share of total joint procedures, the demand for technologies that optimize both clinical and economic performance has never been greater. OrthAlign's Lantern ASC is built upon the success of over 450,000 OrthAlign procedures. As the market demands operational efficiency and financial stewardship, OrthAlign is well-positioned to serve its next half-million patients as the industry leader in accessible technology.

About OrthAlign, Inc.

OrthAlign is a medical device company with a focus on delivering practical, cutting-edge technologies for orthopedic surgery. With a commitment to innovation and excellence, OrthAlign provides surgeons with user-friendly, cost-effective solutions to improve patient care in joint replacement.

Driven by the belief that everyone deserves exceptional healthcare, we are committed to making empowering technologies accessible to all.

For more information regarding OrthAlign, please visit www.orthalign.com.

Lantern is a registered trademark of OrthAlign, Inc.

SOURCE OrthAlign