(79 days)
The EBI® Distal Radius Plating System is indicated for the fixation of fractures and osteotomies involving the distal radius.
The EBI® Distal Radius Plating System is intended to provide fixation of fractures and osteotomies involving the distal radius. The System is comprised of an array of plates and screws, which will provide fixation of the distal radius.
The provided text is a 510(k) Summary for the EBI® Distal Radius Plating System and the FDA's clearance letter. However, it does not contain any information about acceptance criteria, device performance testing, or study results.
The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) submission would.
Therefore, I cannot provide the requested information from the given text. The document states:
"There are no significant differences between the EBI® Distal Radius Plating System and other currently marketed internal fixation systems. It is substantially equivalent to the predicate device in regards to intended use, materials, and function."
This indicates that the device's clearance was based on its similarity to existing devices, not on a new study that proves it meets specific performance 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.