OrthAlign has received US FDA 510(k) clearance for Lantern ASC, a handheld orthopaedic navigation system designed for ambulatory surgery centre workflows.

The clearance addresses a growing operational need in orthopaedics as more total joint arthroplasty procedures shift from hospitals to outpatient and ambulatory settings. While robotic systems have gained traction in joint replacement, their capital cost, infrastructure requirements, setup times and implant-related restrictions can limit adoption in smaller or efficiency-focused centres.

Lantern ASC is designed to deliver real-time navigation for total knee, partial knee and gap balancing procedures across primary and revision cases. The system pairs a reusable navigation unit with a procedural Smart Pack Kit and is intended to integrate with existing Lantern instrumentation.

The platform’s differentiation lies in its portability and ASC-focused economics. OrthAlign positions Lantern ASC as a lower-complexity alternative to robotic systems, with compatibility across most implant systems and no requirement for large fixed infrastructure. This may be relevant for centres seeking advanced navigation capabilities without major capital investment.

The system also builds on OrthAlign’s clinical and commercial experience, with the company reporting more than 450,000 OrthAlign procedures completed to date. Such procedural scale may support surgeon familiarity and confidence as the company expands its ASC-specific offering.