(64 days)
The OrthoPediatrics PediPlate system is used for adult and pediatric patients as indicated for pelvic, small and long bone fractures. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerous, ulna, middle hand and middle foot bones, treatment of the calcaneal; hip arthodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children.
Specific pediatric conditions/diseases for which the devices will be indicated include:
- Valgus, varus, or flexion, extension deformities of the knee (femur and/or tibia) .
- Valgus, varus, or plantar flexion deformities of the ankle .
- Valgus or varus deformities of the elbow (humerus) .
- Radial or ulnar deviation, flexion or extension deformities of the wrist (radius) .
The two and four-hole plates feature a contoured mid-section and low profile for pediatric use. There is an alignment mark in the center of the O and I-Plates to aid accurate placement of the device relative to the growth plate that is localized radiographically. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is transfixed to bone using two to four screws, depending on which plate is selected.
- Materials: The devices are manufactured from 316L stainless steel, which meet . ASTM F138 or ASTM F139.
- . Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
The OrthoPediatrics PediPlate ™ System is intended for use in the treatment of pelvic, small and long bone fractures, as well as deformity corrections of pediatric patients' long bones, which includes osteotomies and redirecting the angle of growth of children's long bones. The system includes cortical and cannulated screws, and specialty plates, referred to as O, I, and H -Plates.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) submission for the OrthoPediatrics PediPlates™ System, discussing its description, indications for use, and substantial equivalence to predicate devices. It does not contain any details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as described in your request.
Therefore, I cannot populate the table or answer the specific questions about a study based on 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.