Meduloc Secures FDA Clearance for Novel Intramedullary Fracture Fixation System

Meduloc, a medical device company focused on advancing orthopaedic surgery, has received 510(k) clearance from the US Food and Drug Administration for its proprietary intramedullary fracture fixation system. The approval represents a major milestone as the company introduces a new category of fixation designed for small, long bone fractures.

The Meduloc system uses a flexible nitinol implant paired with a deployable prong locking mechanism, offering both rotational and length stability. Its design allows surgeons to avoid entering through the joint capsule, a technique that may reduce complications, simplify surgery, support earlier mobility, and speed up recovery. The platform is intended for multiple fracture types—including metacarpal, radius, ulna, clavicle, and fibula injuries—across adult and paediatric patients.

With regulatory clearance in place, Meduloc is preparing for a focused US launch while expanding its surgeon advisory network and clinical partnerships. The company says the approval validates its technology and strengthens its goal of elevating fracture care in a largely underserved market.

15-11-2025