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This product is a unilateral external fixation device, which is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

The Orthofix Dynamic Axial Fixation System, like most external fixation systems, includes various frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are necessary so that the physician can effectively treat diverse kinds of hard tissue maladies that arise due to differences in the anatomical location and the state of the soft tissues and bone, as well as any peculiarities specific to the individual case.

This document is a 510(k) summary for the Orthofix Dynamic Axial Fixation System, primarily aimed at notifying the FDA of a change in distributors. It focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain information related to device performance in terms of acceptance criteria, study results, or AI-specific details.

The document states:

• The components described in the submission have all entered legal distribution in the U.S. as a result of the FDA's clearance of premarket notification K831576.
• Orthofix is submitting this application to notify FDA of the change in distributors and to clarify the FDA record.
• The device itself remains unaffected by the change in distribution practice, and is substantially equivalent to itself.
• None of the components added following the expiration of the distribution agreement with EBI represent changes which could significantly affect the safety or effectiveness of the device and do not alter the substantial equivalence of the system.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, or AI-specific information because it is not present in the provided text. This document is administrative in nature, addressing a change in distribution rather than presenting new performance data.

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