(62 days)
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Synthes LCP ® Dynamic Helical Hip System is a plate and screw system that consists of a straight plate with an angled barrel that accepts a helical blade. The plates have a grooved undersurface, contain combination locking and dynamic compression holes and are available in various barrel angles and plate lengths. The sideplate combination holes accept 5.0 mm locking screws and 4.5 mm cortex screws.
The provided text is a 510(k) summary for the Synthes (USA) LCP® Dynamic Helical Hip System™. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies as requested in the prompt.
The document focuses on demonstrating substantial equivalence to a predicate device based on device description, indications for use, and material, as part of the FDA regulatory process. It states: "Documentation is provided which demonstrates that the Synthes LCP® Dynamic Helical Hip System is substantially equivalent to other legally marketed Synthes devices." This implies that the device's performance characteristics, including safety and effectiveness, are considered comparable to an already approved device, rather than requiring a detailed study against specific acceptance criteria outlined in this document.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness as this information is not present in the provided text.
§ 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.