SutureTech Announces FDA 510(k) Clearance for RapidFix™,Its All – Suture Staple Device for Soft Tissue Repair

Durham, NC — September 16, 2025 — SutureTech, a surgeon-founded medical device company focused on 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.

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.

“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.”

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.

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