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XTRAFIX® External Fixation System
The XTRAFIX External Fixation System includes various elements including clamps, posts, bars, and fixation pins. The elements are used to create assembled frames. External fixators are intended for single use only. The elements in the fixator system are made of several materials including: aluminum, stainless steel, titanium, and composite materials. The fixation pins are manufactured from stainless steel (ASTM F 138).
The XTRAFIX External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries;
- Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Stabilization of fractures in the context of polytrauma;
- Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries;
- Arthrodesis and osteotomies with associated soft tissue problems;
- Stabilization of limbs after removal of total joint (knee and ankle) arthroplasty for infection or other failure;
- Neutralization of fractures stabilized with limited internal fixation;
- Stabilization of non-unions; and
- Intra-operative temporary stabilization tool to assist with indirect reduction.