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The ELEOS™ and ELEOS™ Limb Salvage System with NanoCept® Technology 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™ and ELEOS™ Limb Salvage System with NanoCept® Technology 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 ELEOS™ Limb Salvage System with NanoCept® Technology 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 ELEOS™ Limb Salvage System, a reconstruction implant system intended for joint replacement, limb salvage, and restoration of limb function. The subject technology consists of 510(k)-cleared limb salvage systems (i.e., ELEOS™ Limb Salvage System) and applies an antibacterial coating to certain cobalt chromium (CoCr) components.

The ELEOS™ Limb Salvage System with NanoCept® Technology includes components that have been modified with an antibacterial coating, which includes a covalently bound Quaternary Ammonium Compound (QAC), specifically 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB). The purpose of the antibacterial coating is to reduce bacterial contamination on the surface of the device prior to implantation, by killing bacteria external to the patient which deposit onto the device surface from the operating environment. This coating is not intended to act in or on the body of the patient but rather reduces contamination on the surface of the device prior to implantation.

The purpose of this 510(k) submission is to introduce the ELEOS™ Limb Salvage System with NanoCept® Technology (Proximal Tibia component of the Proximal Tibia assembly) manufactured with cobalt-chromium (CoCr) substrate material cleared in the original predicate device K161520 with an added MDPB coating used in the predicate ELEOSx™ Limb Salvage System DEN210058. This modification aims to expand the product portfolio by adding a CoCr proximal tibia with MDPB coating.

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