(77 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.