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The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip. This submission adds an additional indication for the use of this device with bone cement.

The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip. A small bolus of doughy bone cement is placed into the dome before it is mounted on the insertion tool. After insertion into the femur, the tool is tightened to extrude the cement into the surrounding cancellous bone. The addition of the bone cement provides enhanced early stability, reduced risk of superior cut-out and the ability to bear higher loads. The submission also describes several minor modification to the design of the device.

This document is a 510(k) Summary for a medical device (Alta® Dome and Plunger, MEC Hip Bolt). It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.

However, this document does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria (such as sensitivity, specificity, or accuracy).

Therefore, I cannot fulfill your request for the detailed information outlined in points 1 through 9. The document is solely focused on regulatory clearance based on substantial equivalence, not on performance studies against predefined acceptance criteria.

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