(75 days)
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, .
- Osteotomy and repair of distal radius malunion with or without bone graft. .
The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
The provided text is a 510(k) summary for a medical device (Distal Radius Fracture Fixation Plate System) and does not contain information about acceptance criteria or a specific study proving the device meets certain performance metrics through data analysis.
Instead, this document describes:
- Substantial Equivalence: The primary focus is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices (Orthomet K943853 and Synthes K953644). This means it has the same intended use and similar technological characteristics, and therefore, does not raise new questions of safety and effectiveness.
- Device Description: A general overview of the components.
- Intended Use: The specific medical conditions the device is designed to treat.
- Comparison to Predicate Devices: A table highlighting similarities and differences in features like implantability and material (all are 316L).
- Regulatory Information: The FDA's letter granting market clearance, outlining general controls, specific labeling requirements (especially regarding pedicular screw fixation), and other regulatory obligations.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because it is not present in the provided text. The traditional type of performance study (e.g., clinical trial, standalone algorithm performance, or MRMC study) with quantitative acceptance criteria and detailed methodology is not part of a 510(k) summary for this type of device, which relies heavily on demonstrating substantial equivalence to existing devices.
§ 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.