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The ELEOSTM/ELEOSx™ Limb Salvage System is indicated for resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur. and proximal tibia in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, traumatic arthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed: and. 5) Treatment of fractures that are unmanageable using other techniques. The ELEOS™/ELEOSx™ Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip or knee arthroplasties, and/or Oncology indications. 3) Metastatic diseases. The ELEOSx™ MDPB coating, where applied, is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device components. The clinical impact associated with the MDPB coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The MDPB coating is not intended to treat existing infections and does not act within or on the body.

The Onkos Surgical ELEOSx™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The systems include components manufactured from cobalt-chrome alloy (CoCr), titanium alloy (TAV), and ultra-high molecular weight polyethylene (UHMWPE). Non-articulating CoCr component surfaces are coated with 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB), which is intended to reduce bacterial contamination on the surface of the device components prior to implantation resulting from deposition in the operating room. Based on in vitro testing, this coating may result in immobilization and/or lysis of some challenge organisms. The MDPB coated CoCr stems are for cemented use in the reconstruction/replacement of the lower limb. The reconstruction applications are proximal femur, intercalary portion of the femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS™ Limb Salvage components are femoral head, proximal femur, female stem, mid-section, stem, distal femur, tibial hinge component, axial pin. tibial poly spacer, tibial baseplate, malemale mid-section, resurfacing femur, proximal tibia, tapered screws, patella, stem extension, tibial wedges, and augments. Instruments included in the Onkos ELEOSx™ Limb Salvage System are used in implantation and removal of the system components.