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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.

The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

The subject submission adds locking screw component options and associated instrumentation to the subject My3D® Personalized Pelvic Reconstruction system. The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint. This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components. The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint. This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components. The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

The ELEOS™ 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, 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 Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the 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 Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction 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, segmental stem, distal femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial baseplate, male-male mid section, resurfacing femur, proximal tibia, patella, stem extension, and tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

ELEOSTM Limb Salvage System Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions : 1) Non-inflammatory degenerative joint disease such as osteoarthritis, 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and or total femur is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment: 2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. - 3) Metastatic diseases ELEOSTM Limb Salvage System Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, optional components include modular collars, patella, stem extensions, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.

ELEOSTM Limb Salvage System with Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) Metastatic diseases ELEOS™ Limb Salvage System with Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: l ) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the is required with the following conditions: 1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal femur, tibial hinge component, axial pin, tibial poly spacer, tibial baseplate, male-male mid-section, resurfacing femur, proximal tibia, tapered screws, patella, stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

ELEOSTM Limb Salvage System with Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) Metastatic diseases ELEOS™ Limb Salvage System with Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: l ) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the is required with the following conditions: 1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. - 3) Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male-male mid-section, resurfacing hinge femur, and proximal tibia, patella, stem extension, modular collar, tibial wedges and augments.

The ELEOSTM Bipolar Acetabular System is indicated for the following conditions: 1) pathological fractures of the femoral neck 2) non-union of femoral neck fractures 3) aseptic necrosis of the femoral head and neck 4) primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

ELEOS™ Bipolar Acetabular System is a bipolar hip implant design that features a cross-linked polyethylene bearing surface with a lock detail enhanced for strength. Historical concerns with traditional bipolar designs have included loosening of the insert, disassociation of the head from the shell, and osteolysis resulting from polyethylene wear. This system is designed to address these concerns to give surgeons greater confidence when using a bipolar implant. There is an UHMWPE support ring inside the shell that is permanently fixed. There is also an UHMWPE locking ring that assembles above the support ring and locks into place once the head is inserted into the shell. Bipolar heads are available in a variety of diameters with corresponding internal diameters for 22, 28, 32 and 36mm femoral heads with skirts are not compatible with the bipolar shells.

ELEOSTM Limb Salvage System Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) Metastatic diseases ELEOSTM Limb Salvage System Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; - 2) Inflammatory degenerative joint disease including 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. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma. revision knee arthroplasties, and/or Oncology indications. - 3) Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, patella. stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.