Durham, NC—September 16, 2025—SutureTech, a surgeon-founded medical device company focusedon advancing soft tissue and tendon repair, today announced that the U.S. Food and Drug Administration(FDA) has granted 510(k) clearance for RapidFix™,its flagship device. Cleared by the FDA as theAll-SutureDual Anchor System, RapidFix™ is intended for fixation of soft tissue to bone in a variety oforthopedicprocedures.

This clearance marks a major milestone in SutureTech’s mission to deliver clinically informed, surgeon-driven solutions that simplify complex procedures and expand market opportunities in musculoskeletal repair.

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“Achieving FDA clearance for RapidFix™ is a defining moment for SutureTech,” said Dr. Oke Anakwenze, Founder & CEO of SutureTech and Chief of Shoulder Surgery at Duke University. “The device was designed to streamline surgical steps while maintaining strong, reliable fixation. We believe RapidFix™ offers value for surgeons seeking reproducibility—and for patients who benefit from more consistent repairs.”

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Designed by Surgeons, for Surgeons
RapidFix™ is a 100% suture-based internal fixation device engineered to create secure tendon-to-bone repairs while reducing procedural steps and surgical complexity. Developed through eight years of surgeon-led collaboration, the device has been validated through preclinical testing for safety and performance.

“As a practicing orthopedic surgeon, I know the real-world challenges of rotator cuff and tendon repairs,” added Dr. Anakwenze. “RapidFix™ was born out of that experience to give surgeons a simple, reproducible tool that can be integrated seamlessly into the operating room.”

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Commercialization & Growth Strategy
Following clearance, SutureTech will initiate a limited market release of RapidFix™ in Q4 2025, which will launch through a phased rollout to establish clinical adoption and operational readiness. Preparations for a broader U.S. commercial rollout are already underway, supported by partnerships with key opinion leaders (KOLs), strategic distribution channels, and ongoing pipeline development.

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SutureTech was selected for MedTech Innovator’s 2025 Accelerator Cohort in the Surgical & Orthopedic category—the world’s largest and most impactful accelerator for medical technology startups. As one of just 64 startups chosen from nearly 1,500 global applicants, this recognition underscores SutureTech’s position as a high-potential medical technology company.

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About SutureTech
SutureTech is a surgeon-founded medical device company focused on advancing soft tissue and tendon repair. Headquartered in Durham, North Carolina, SutureTech develops internal fixation implants and surgical instruments designed to support efficient, reliable procedures across a range of orthopedic applications.

Built on clinical insight and driven by innovation, SutureTech brings together engineering precision and real-world surgical experience to create solutions that meet the demands of today’s operating rooms. Each product reflects a commitment to quality, anatomical adaptability, and procedural consistency.

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To learn more, visit www.suturetech.com
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