(58 days)
The DHS/DCS Plate System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones.
The system makes up of DHS/DCS Plates, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5 mm Cortex Screw (self-tapping). The DHS Plates are available with barrel length 25 mm and 38 mm, and barrel angles 135°, 140°, 145°, and 150° . The standard barrel length is 38 mm. Otherwise, the self-tapping 4.5 mm Cortex Screw may be used to fix the DHS/DCS Plates to the femoral shaft.
The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26 mm and outer diameter 4.0 mm.
The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Screw is available with thread length 22 mm, total length from 50 to 145 mm, outer diameter 12.5 mm, and shaft diameter 8.0 mm.
The provided text describes a 510(k) summary for the Syntec-Taichung Non-sterile DHS/DCS Plate System, a medical device for fixing proximal femur fractures. The document indicates that the device has been found substantially equivalent to predicate devices, but does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document is primarily a regulatory approval letter and a summary of the device's basic characteristics and intended use.
§ 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.