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The Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

Synthes EIN is a flexible intramedullary fixation device. The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm in length, which can be cut to size intraoperatively. The EIN has a curved tapered tip to facilitate insertion and manipulation. The EIN is made of a titanium alloy (Ti-6Al-7Nb).

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) summary for the Synthes Elastic Intramedullary Nail (EIN) System, detailing its intended use, classification, and predicate device. It includes the FDA's clearance letter for the device, confirming its substantial equivalence to previously marketed devices.

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