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The Monkey Rings™ External Fixation System is intended to be used in adults and pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).

The Monkey Rings External Ring Fixation System is intended to treat the following patient indications in pediatric patients and adults for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g., orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Monkey Rings External Ring Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Monkey Rings External Ring Fixation System is a modular, ring-based external fixation system intended for the treatment and fixation of a variety of orthopedic conditions in pediatric and adult patients. The system is designed to stabilize bone segments during fracture management, deformity correction, or limb lengthening procedures. It consists of multiple components, including rings, connecting rods, struts, bolts, fasteners, clamps, plates, pins, and Kirschner wires (K-wires), which can be assembled in various configurations to provide either static fixation or gradual adjustment of bone position. The modular design allows surgeons to tailor the construct to meet specific anatomical and clinical needs.

The subject components included in this submission are the Universal Joint Struts and updated sterilization parameters for the system. The Universal Joint Strut is a newly introduced component designed to allow precise modification of strut length and controlled repositioning of the fixation rings over time. Its universal joint mechanism provides enhanced angular flexibility, enabling improved intraoperative adjustability and postoperative frame modification while maintaining structural stability and fixation integrity. All other components of the Monkey Rings External Ring Fixation System, including rings, connecting rods, and associated fixation hardware, were previously cleared and remain unchanged in design and function.

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