(62 days)
The SBI Hand Fixation System™ is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.
The SBI Hand Fixation System™ consists of a series of stainless steel plates and screws of varying lengths and thicknesses and is provided in various configurations, including straight, T-, Y-, Z-, compression L-, compression T-, and compression Y-plates. These plates are attached to bone via 1.5, 1.7, 2.0, 2.2, 2.4, and 2.6mm self tapping cortex screws.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study details that would allow me to populate the requested table and answer your questions. The document is a 510(k) summary and the FDA's response letter for the SBI Hand Fixation System, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance data or study methodology.
§ 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.