OrthAlign Wins FDA Nod for Lantern ASC System

OrthAlign has earned U.S. Food and Drug Administration (FDA) 510(k) for the Lantern ASC system, a solution the company said delivers advanced technological precision at a fraction of the cost and complexity of robotic systems.

Robotic systems need massive upfront investment, lengthy setup times, and steep learning curves in the operating room. Lantern ASC was built for the realities of the ambulatory surgery center (ASC) environment and pairs a reusable navigation unit with a procedural Smart Pack Kit for real-time navigation for total knee, partial knee, and gap balancing in primary and revision surgeries.

The portable and scalable solution was designed to integrate with existing Lantern instruments and is compatible with most implant systems, OrthoAlign said.

“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 company’s Lantern ASC is built on the success of more than 450,000 OrthAlign procedures.

“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.”

In April, the company obtained CE mark clearance for its lineup of handheld navigation solutions, including both the Lantern and OrthAlign Plus platforms.