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. Cleared by the FDA as the All-Suture Dual Anchor System, RapidFix™ is intended for fixation of soft tissue to bone in a variety of orthopedic procedures.
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.
