(168 days)
The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults.
Specific indications include:
- intertrochanteric derotation and varus osteotomies (100° and . 110° plates)
- femoral neck and petrochanteric fractures (120° plates) .
- intertrochanteric valgus osteotomies (150° plates)
The Synthes (USA) Pediatric LCP Hip Plate System is available in 3.5 and 5.0 mm versions which include 100, 110, 120, and 150 degree angles. The plates are designed with three conical locking screw holes located at the head in conjunction with 3 or 4 combination locked-compression screw holes at the shaft. The fixed angle construct is created by means of three standard locking screws inserted through the head of the plate. The shaft of the plate accepts locking or cortex screws, depending on the nature of the fracture or the quality of bone.
In addition, the plates are manufactured from 316L stainless steel and available both sterile and non-sterile.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary and corresponding FDA letter for the "Synthes (USA) Pediatric LCP Hip Plate System," which outlines the device description, intended use, and substantial equivalence to a predicate device. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot generate the requested table and information.
§ 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.