(73 days)
The VariAx™ Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.
This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Distal Fibula Plate are intended to add a different type of plate to the Stryker® Plating System portfolio.
This is a 510(k) premarket notification for a medical device (VariAx™ Distal Fibula Plate), not a study report for an AI/ML powered device. As such, the information requested in the prompt (acceptance criteria, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or available in this document.
The document mainly focuses on establishing substantial equivalence to previously marketed devices based on intended use, design, materials, and operational principles, rather than performance metrics from a clinical study using specific acceptance criteria.
Therefore, I cannot provide the requested table and study details.
§ 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.