ELEOSx™ Limb Salvage System

The ELEOS™/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.