(37 days)
The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include:
- Diaphyseal fractures of the humeral shaft
- Fractures of the proximal humerus
- Proximal humeral fractures with diaphyseal extension
- Impending pathologic fractures
- Malunions and nonunions
The Synthes Titanium Cannulated Humeral Nail System consists of cannulated titanium intramedullary rods, and end caps in a variety of sizes designed for treatment of various humeral fractures. A 2.0mm guide wire is used with the system.
My apologies, but the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Synthes Titanium Cannulated Humeral Nail System), which primarily focuses on establishing substantial equivalence to a legally marketed predicate device.
Specifically, the document states: "Documentation is provided which demonstrated the Synthes Titanium Cannulated Humeral Nail System to be substantially equivalent to other legally marketed devices." This indicates that the regulatory pathway chosen was based on comparing the new device to existing ones rather than presenting performance data against pre-defined acceptance criteria from a specific study.
Therefore, I cannot provide the requested information, as it is not present in the given 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.