(20 days)
Knee Fusion Nails are for intramedullary knee arthrodesis.
A Knee Fusion Nail is inserted into the medullary canal of long bones for knee arthrodesis. The design of the Knee Fusion Nail is based on Smith & Nephew's (formally Richards Medical) experience with intramedullary nail systems, which dates back to the 1950's. The Knee Fusion Nail includes intramedullary interlocking nails with corresponding screws. The Knee Fusion Nail and corresponding screws are made of Ti-6Al-4V titanium alloy with holes/slots for optional locking screws on both ends of the nail. Locking screws are available for optional and distal locking. Screws are available in 5.0mm, and 6.4mm diameters with varying lengths. The screws were previously cleared in 510(k) K981529. The device is intended for single use.
The provided document is a 510(k) summary for a medical device called "Knee Fusion Nail". It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information regarding acceptance criteria for performance, clinical study data involving a test set, expert adjudication, or AI/human reader studies.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to existing devices, not on detailed performance metrics from a dedicated clinical study with specific acceptance criteria.
§ 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.