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The CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures of the pelvis.

The CurvaFix Intramedullary Rodscrew System is a collection of flexible intramedullary devices for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the Rodscrew from a flexible to rigid state after implantation. The Rodscrew can be returned to a flexible state should explantation be required. The implants are available in a single diameter and an assortment of lengths to accommodate a variety of anatomic requirements.

The provided text describes a medical device, the CurvaFix Intramedullary Rodscrew System, and its FDA 510(k) clearance. However, it does not contain information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing according to ASTM standards. It confirms the materials, intended use, and technological characteristics are similar to existing cleared devices, concluding that the CurvaFix system is substantially equivalent.

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