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The Lorenz Maxilla (Le Fort) Distraction System is intended for use in the maxilla as a bone stabilizer and lengthening device when correction of congenital midfacial deficiencies or post traumatic defects require gradual bone distraction.

This device is a linear distractor with a drive screw and two connection plates. Normally both a left and right device is implanted together. The two plates cap the resected zygoma such that the screws only prevent the device from slipping but are not relied upon to carry the distraction load. The device is placed internally with the drive mechanism protruding through the skin anteriorly. Two lengths for the threaded rod will allow up to 32mm (1.27") of distraction. After distraction is complete, the drive mechanism can be detached and the plates and screws and drive screw may be left under the skin. The device is advanced using a separate torque wrench.

The provided text describes a medical device submission (K982604) for the Lorenz Maxilla (Le Fort) Distraction System. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document appears to be a summary of safety and effectiveness, an FDA clearance letter, and an indications for use statement, which are typical components of a 510(k) submission for demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details. The information necessary to answer your request is not present in the provided text.

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