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Blue Belt Earns CE Mark for Stride Knee System
Orthopedic instruments maker Blue Belt Technologies said Wednesday that it received a CE mark for its Stride unicondylar knee system, paving the way for distribution in countries that observe the mark.
The system is indicated for medial and lateral unicompartmental knee replacements, and is optimized to be implanted with Blue Belt’s robotic Navio system. The open-platform Navio system helps perform bone- and joint-shaping tasks through minimal incisions, the Plymouth, Minn., devicemaker said.
President and CEO Eric Timko called the CE Mark an important milestone as the company continues to expand its commercial footprint outside the U.S. Early clinical outcomes and physician feedback have been positive, he said.
Stride received FDA clearance in June 2014 and was commercially launched in the U.S. in October. — Kellen Owings