(19 days)
The Smith & Nephew Locking Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Components in the Smith & Nephew Locking Bone Plate System are for single use only.
The Smith & Nephew Locking Bone Plate System is a modification of the Smith & Nephew Bone Plate System cleared under K993106. Like the predicate devices listed below, components include various sizes of contoured and straight, locking bone plates, locking bone screws, and compression screws made from stainless steel. Implantable locking plates/screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
The provided text does not contain information about acceptance criteria, device performance, or any studies with specific details like sample sizes, ground truth establishment, or expert involvement. The document is a 510(k) summary for the Smith & Nephew Locking Bone Plate System, primarily focused on establishing substantial equivalence to previously cleared predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the specified 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.