Lake Forest, CA – 2024– Biodynamik Inc., an innovative engineering-focused company specializing in advanced orthopedic procedures and medical technologies, proudly announces FDA 510(k) clearance for its XT3 System. The XT3 System is specifically designed to perform transverse bone transport in the tibia, representing meaningful progress in advancing the Transverse Tibial Transport (TTT) procedure in the United States.

Biodynamik officially opened its doors in February 2024 with a bold mission to transform patient care. In less than one year, the company has developed and achieved clearance for its first product, an extraordinary accomplishment in the competitive and highly regulated medical device industry. In addition to fracture fixation, XT3 System is designed to streamline the transverse bone transport procedure, making it more patient-friendly and accessible for wider adoption.

“Receiving FDA 510(k) clearance for the XT3 System is a testament to our team’s dedication to engineering excellence, innovation and patient care,” said Johnny Chen, CEO of Biodynamik Inc. “By introducing this life-changing technology to the U.S., we are uniting global expertise to bring new hope to patients in need. Achieving this milestone in such a short time demonstrates the incredible potential of our team to deliver transformative solutions for patients and healthcare providers alike.”

Dr. Qikai Hua, the pioneer of the TTT technique, shared his excitement: “After decades of developing TTT in China, it is immensely gratifying to see this brought to the Western world through Biodynamik. Their efforts to bridge the global medical community are not only honoring our research but also paving the way for adoption in the United States. I look forward to seeing how this technique will transform care and improve outcomes for patients.”

Dr. David G. Armstrong, a leading authority on limb salvage, also commented: “The FDA clearance of Biodynamik’s XT3 System is a significant step forward in advancing the Transverse Tibial Transport technique. By streamlining the procedure and making it more patient-friendly, the XT3 System paves the way for wider adoption of this truly disruptive approach.”

About Biodynamik

Biodynamik, Inc. develops orthopedic external fixation systems. The XT3® System is FDA 510(k) cleared for fracture fixation, nonunion, transverse bone transport of the tibia, and the correction of bony or soft tissue defects and deformities in adult patients. Biodynamik is sponsoring the SMILE-TTT study (IDE G260049) of transverse tibial transport in patients with diabetic foot ulcers; this use is investigational.