IRVINE, Calif., April 20, 2026 /PRNewswire/ — OrthAlign, Inc., the leader in handheld orthopedic enabling technology, today announced it has received CE Mark under the EU MDR for its portfolio of navigation solutions, enabling commercialization across European markets. Both the Lantern® and OrthAlign Plus® platforms are now CE marked and available for sale.

This milestone expands access to OrthAlign’s proven technology across a region increasingly focused on efficiency, flexibility, and cost control in joint replacement.

OrthAlign’s handheld systems are well aligned with the needs of European healthcare systems. Delivered in a single-use format with per-case pricing, the technology eliminates the need for capital equipment, service contracts, and complex infrastructure. Hospitals and ambulatory surgical centers can more easily manage costs while maintaining access to advanced surgical technology.

“Our technology was designed to be accessible and easy to implement,” said Eric Timko, CEO of OrthAlign. “With no pre-operative imaging requirements, minimal training, and rapid product availability, we enable surgeons to adopt technology without disrupting existing workflows.”

OrthAlign’s open-platform supports compatibility with all major implant systems, giving surgeons flexibility across techniques and preferences while helping facilities standardize solutions across sites of care. It delivers consistent outcomes across total knee, revision knee, partial knee and total hip procedures.

With more than 450,000 procedures performed globally, OrthAlign has established a strong track record of delivering accurate, real-time data while maintaining procedural efficiency. The systems are designed to integrate seamlessly into the operating room, offering time-neutral performance compared to manual techniques without the added complexity of traditional navigation or robotics.

“The European market is increasingly prioritizing solutions that balance clinical performance with operational and economic efficiency,” added Timko. “We believe OrthAlign is uniquely positioned to meet that need.”

OrthAlign will begin immediate commercial rollout in key European markets, supported by distribution partners and clinical education programs. For distribution inquiries please contact info@orthalign.com. 

About OrthAlign

OrthAlign, Inc. is a global medical device company focused on delivering simple, accurate, and cost-effective handheld technology for joint replacement surgery. Its product portfolio, including OrthAlign Plus and Lantern, empowers surgeons with real-time data to improve alignment and procedural efficiency, without the need for capital equipment.

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SOURCE OrthAlign