Search Results

This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.

The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for an external fixation system, which describes the product, its intended use, and compares it to substantially equivalent products. It does not include details about device performance metrics, studies, or clinical trial data as requested in your prompt.

Ask a specific question about this device