CE Mark Granted to OrthAlign for Handheld Navigation Solutions

OrthAlign Inc. has received CE Mark approval for its portfolio of navigation solutions, including both the Lantern and OrthAlign Plus platforms. This regulatory milestone expands access to the company’s technology in a region focused on efficiency, flexibility, and cost control in joint replacement.

OrthAlign’s handheld systems are single-use with per-case pricing. The technology eliminates the need for capital equipment, service contracts, and complex infrastructure, according to the company.

“Our technology was designed to be accessible and easy to implement,” OrthAlign CEO Eric Timko said. “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 is compatible with all major implant systems, thus giving surgeons flexibility across techniques and preferences while helping facilities standardize solutions across care sites. It delivers consistent outcomes across total knee, revision knee, partial knee and total hip procedures.

With more than 450,000 procedures performed globally, OrthAlign claims to have established a strong track record of delivering accurate, real-time data while maintaining procedural efficiency. The systems integrate seamlessly into the operating room, offering time-neutral performance compared with manual techniques and 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,” Timko stated. “We believe OrthAlign is uniquely positioned to meet that need.”

OrthAlign will immediately roll out its handheld systems key European markets with its distribution partners and clinical education programs.

OrthAlign Inc. is a global medical device company delivering simple, accurate, 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.