Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 32832 - uncoated knee tibia prosthesis, metallic - the pfc sigma modular plus tibial tray is made of a titanium alloy and is intended for cemented use during revision or primary total knee arthroplasty. the modular stem attachment of the offset variant is offset medially from the centre of the plateau which provides optimal proximal tibial plateau coverage while also facilitating proper stem placement in the intramedullary canal. the pfc sigma modular plus tibial tray is the tibial component which holds the insert component of a total knee arthroplasty. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 33580 - uncoated knee tibia prosthesis, polyethylene - the pfc sigma posterior stabilised all poly insert replaces the tibial condyles during bicondylar replacement of the knee joint; it is made entirely of polyethylene. the device is designed to articulate directly with the femoral prosthetic component and its implantation is intended to be performed with bone cement. the pfc sigma posterior stabilised all poly insert is the tibial component of a total knee arthroplasty. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total or unicompartmental knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 32832 - uncoated knee tibia prosthesis, metallic - the pfc sigma modular tibial tray - cocr is fixed bearing and designed to replace the tibial condyles during bicondylar replacement of the knee joint and is made of cocr with a highly polished top surface. the i2 locking mechanism locks in the tibial insert which decreases micro-motion. implantation is intended to be performed with bone cement. the pfc sigma modular tibial tray - cocr is the tibial resurfacing component which holds the insert component of a total knee arthroplasty. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 33745 - coated knee femur prosthesis - the pfc sigma cruciate retaining porous femur is a primary bicondylar replacement prosthesis made of metal cobalt chrome and is intended for cemented or cementless use as the femoral component of a total knee replacement system. it articulates with the tibial insert of a knee joint prosthesis. it is coated with porocoat intended to improve fixation and stability by promoting bone ingrowth. the pfc sigma cruciate retaining (cr) porous femur are bicondylar femoral components which articulate with the insert component of a total knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 32831 - uncoated knee femur prosthesis - the pfc sigma cruciate sacrificing non porous femorals are a primary bicondylar replacement prosthesis made of metal cobalt chrome, its implantation is performed with bone cement. it articulates with the tibial insert of a knee joint prosthesis. the pfc sigma cruciate sacrificing non porous femurs are the femoral component used in total knee arthroplasty and articulate with the insert component. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 32831 - uncoated knee femur prosthesis - the pfc sigma tc3 femoral is manufactured from co-cr-mo alloy and is uncoated for cemented fixation. the femoral condylar component matches the tibial bearing component. the pfc sigma tc3 femorals allow for the attachment of femoral augments, sleeves, and ancillary p.f.c. stem extensions to provide additional stability to accommodate for femoral bone loss. the pfc sigma tc3 femur is the femoral component of a total knee arthroplasty and for revision of failed knee prostheses. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/ or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 46585 - prosthesis, knee, internal, insert component - the pfc sigma tc3 fixed bearing inserts are made from uhmwpe and reinforced with titanium pins. the pin is part of the spine and protrudes down through the bottom of the insert. it is inserted into the hole of the modular tibial tray. the pfc sigma tc3 fixed bearing insert locks into the tibial tray and articulates with the femoral component. p.f.c sigma tc3 tibial fixed bearing inserts are offered in the same sizes as the femoral components with dimensions that correspond to the tibial tray. the pfc sigma tc3 fixed bearing insert is the articulating component of a total knee arthroplasty and for revision of failed knee prostheses. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 32832 - uncoated knee tibia prosthesis, metallic - the pfc sigma modular titanium tibial tray replaces the tibial condyles during total knee replacement and articulates with the femoral implant. it is a fixed bearing tibial tray and made from titanium with uhmwpe distal stem plugs. fins support the plateau, resists rotational forces and anterior/posterior rocking of the tibial component. an insert containment rim enhances tray strength and captures the insert. it is non-porous and implantation is intended to be performed with bone cement. the pfc sigma modular titanium tibial tray is the tibial component of total knee arthroplasty. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 32832 - uncoated knee tibia prosthesis, metallic - the pfc sigma keel tibial tray is designed to replace the tibial condyles during bicondylar replacement of the knee joint and is made of titanium. the device is designed to hold the insert which articulates with the femoral prosthetic component of the knee joint. it is non-porous and its implantation is intended to be performed with bone cement. the pfc sigma keel tibial tray is the tibial component which holds the insert component of a total knee arthroplasty. it is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 32831 - uncoated knee femur prosthesis - the pfc sigma cruciate retaining non-porous femur are a primary bicondylar replacement prosthesis made of cobalt chrome. it is uncoated and its implantation is performed with bone cement. it articulates with the tibial insert of a knee joint prosthesis. the pfc sigma cruciate retaining (c/r) non-porous femurs are bicondylar femoral components which articulate with the insert component of a total knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.