BioDynamik Announces New FDA 510(k) Clearance for XT3 System
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.
Transverse Tibial Bone Transport (TTT) is a proven technique that stimulates angiogenesis and restores circulation in ischemic tissues, offering a transformative option for patients with chronic wounds and ischemic conditions who previously faced limited treatment 1.
“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 and proving the efficacy of TTT in China, it is immensely gratifying to see this life-saving technique 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 Inc.
BioDynamik Inc. is a privately held, California-registered medical device company specializing in advanced orthopedic procedures and medical technologies. Based in Lake Forest, California, BioDynamik’s mission is to activate the body’s innate healing potential to save limbs and lives. The company focuses on developing engineering-based solutions that address critical unmet medical needs in limb preservation and chronic wound care.
Chen, Y., et al. (2022). Effect of tibial cortex transverse transport in patients with recalcitrant diabetic foot ulcers: A prospective multicenter cohort study. Journal of Orthopaedic Translation, 36, 194–204. https://doi.org/10.1016/j.jot.2022.09.002