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

Irvine, Calif. (June 3, 2026) – 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.