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The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for: - Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis - Correction of varus, valgus or post traumatic deformity . - . Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement - Ligament deficiencies . - Tumor resection . - Revision of previously failed total joint arthroplasty . - . Trauma - . The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue The Patient Specific SMILES Total Knee Replacement and its components are for cemented use only. The Patient Specific Patient Specific SMILES Total Knee Replacement and its components are for single use only.

The Patient Specific SMILES Total Knee Replacement is a patient-specific system that is intended for the replacement of diseased or deficient bone around the knee joint. The system includes three tibial options: 1) metal cased rotating hinge, 2) fixed hinge, and 3) rotating hinge polyethylene tibia. The Patient Specific SMILES Total Knee Replacement and its components are intended for cemented use only. The materials used in the manufacture of the Patient Specific SMILES Total Knee Replacement include titanium (Ti), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE). The device is for single use only.