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INTENDED USE

The Response Ortho Smart Fixator - Hexapod System is intended for use in adult patients and pediatric patients greater than 2 through 21 years of age for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones, limb lengthening, deformity and angular correction, bony or soft tissue defect correction, and malunions. This is accomplished by construction of an external fixator frame and a computer-assisted planning and correction application. Based on surgeon input of examination and radiographic measurements, the software provides a schedule of adjustments for the fixator frame.

INDICATIONS FOR USE

The Smart Fixator - Hexapod System is indicated for adult patients and pediatric patients greater than 2 through 21 years of age for the following:

• Joint contracture resulting in loss of range of motion.
• Fractures and disease which generally may result in joint contractures or loss of range of motion.
• Fractures requiring distraction.
• Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar).
• Correction of bony or soft tissue defects.
• Correction of bony or soft tissue deformities.
• Joint arthrodesis.
• Infected fractures or nonunion.
• Limb lengthening by epiphyseal or metaphyseal distraction.
• Pseudoarthrosis of long bones.

The Response Ortho Medical Smart Fixator - Hexapod System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the position to adjust the position of one ring relative to the other. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Fixator - Hexapod System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steadily controlled fashion. In addition to the hardware, the Smart Fixator - Hexapod System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images and the fixator parameters into the software. The software is used preoperatively to plan the reconstruction/correction and identify the frame construction. Post operatively, the surgeon enters the X-ray images and the current frame parameters to establish an adjustment schedule for the patient during the healing process.

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