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Fracture reduction and external fixation for treatment of distal radius fractures.

The Agee-WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction/fixation frame (fixator), application instrumentation and skeletal fixation pins.

The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

The provided text is a 510(k) summary for the Agee-WristJack Fracture Reduction System (sterile version). It mainly focuses on demonstrating substantial equivalence to a predicate device by highlighting that the only difference is the sterility of the new device.

Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details related to a performance study for this specific device.

The document states:

• "All the device components and materials of the Agee-WristJack Fracture Reduction System (sterile version) are identical to the device components and materials of the predicate device, except this device is delivered sterile. The predicate device requires customer sterilization prior to use."
• "No performance standards exist for this device."

This indicates that the submission relies on the established safety and effectiveness of the non-sterile predicate device, with the sterile aspect being the primary change, likely supported by sterilization validation studies, not clinical performance studies comparing the new device's efficacy.

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