(65 days)
The SBi StaFIX is indicated for: . Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small bones. . Fixation of soft tissue to bone
The SBi StaFIX System consists of a set of stainless steel staples for internal fixation. The devices are supplied non-sterile and are available in several configurations and sizes.
The provided text is a 510(k) summary for the SBi StaFIX bone fixation system, a medical device. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. It is a regulatory filing for market clearance based on substantial equivalence, not a detailed technical performance study report. Therefore, I cannot extract the requested information from 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.