Search Results

The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the 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-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

The Synthes Stainless Steel Elastic Intramedullary Nail System consists of intramedullary fixation devices that vary in diameters and lengths, which can be cut to size intra-operatively. The nails have a curved tip to facilitate insertion and manipulation. The end cap is inserted over the external portion of the nail and threaded into the cancellous bone.

The provided text describes a 510(k) summary for the Synthes (USA) Stainless Steel Elastic Intramedullary Nail System, which is an intramedullary fixation device.

However, the document does not contain any information about acceptance criteria, device performance metrics, sample sizes for testing or training, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

This submission is a premarket notification to the FDA for substantial equivalence to predicate devices, and as such, it focuses on the device description, intended use, and comparison to existing legally marketed devices, rather than a detailed report of a new clinical study or performance evaluation with specific acceptance criteria and results.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device