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

medacta australia pty ltd - 33580 - uncoated knee tibia prosthesis, polyethylene - the gmk primary ps fixed tibial insert is manufactured from uhmwpe and is designed to be used with the gmk primary femoral and fixed tibial components. the inlay clipping mechanism assures time-effective and safe implantation. gmk fixed ps tibial insert forms part of the gmk primary knee system that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. candidates for total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

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

stryker australia pty ltd - 33580 - uncoated knee tibia prosthesis, polyethylene - a sterile implantable all polyethylene tibial component, designed to be cemented into the tibia and to articulate with an artificial femoral component for a total knee arthroplasty (tka). a tibial component of the triathlon total knee used to replace the tibial plateau of the knee joint. general total knee arthroplasty (tkr) indications: painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease; moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

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

stryker australia pty ltd - 33580 - uncoated knee tibia prosthesis, polyethylene - a sterile implantable all polyethylene tibial component, designed to be cemented into the tibia and to articulate with an artificial femoral component for a total knee arthroplasty (tka). a tibial component of the triathlon total knee used to replace the tibial plateau of the knee joint. general total knee arthroplasty (tkr) indications: painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease; moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. additional indications for posterior stabilized (ps) components: ligamentous instability requiring implant bearing surface geometries with increased constraint; absent or non-functioning posterior cruciate ligament; severe anteroposterior instability of the knee joint.

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 curved all poly tibia is made from polyethylene, is uuncoated and intended for cemented fixation. it is a one piece tibial component/insert that is fixated into the tibia and articulates with the femoral component. the pfc sigma curved all poly tibia is a one piece tibial/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 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 - 33580 - uncoated knee tibia prosthesis, polyethylene - the pfc sigma curved all poly tibia is made from polyethylene, is uncoated and intended for cemented fixation. it is a one piece tibial component/insert that is fixated into the tibia and articulates with the femoral component. the pfc sigma curved all poly tibia is a one piece tibial/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 a failed previous implant.

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

kico knee innovation company pty ltd - 33580 - uncoated knee tibia prosthesis, polyethylene - the madison universal deep dish insert is a fixed or mobile bearing uhmwpe insert with 4 degrees of posterior slope. it attaches to a madison tibial base and articulates with a madison (cruciate retaining) femoral component. the madison universal deep dish insert is a bearing component of the madison total knee replacement system and is intended to replace the knee joint. the main indications are as follows: - degenerative osteoarthritis or post traumatic arthrosis, in patients whose age, weight, and level of activity are compatible with a satisfactory long term result - rheumatoid polyarthritis - revision of unicompartmental arthroplasty procedure, if bone mass and ligament stability allow - failed osteotomy

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

kico knee innovation company pty ltd - 33580 - uncoated knee tibia prosthesis, polyethylene - the madison posterior stabilising insert is a uhmwpe insert with 4 degrees of posterior slope. it attaches to a madison tibial base and articulates with a madison (posterior stabilising) femoral component. the madison posterior stabilising insert is a bearing component of the madison total knee replacement system and is intended to replace the knee joint. the main indications are as follows: - degenerative osteoarthritis or post traumatic arthrosis, in patients whose age, weight, and level of activity are compatible with a satisfactory long term result - rheumatoid polyarthritis - revision of unicompartmental arthroplasty procedure, if bone mass and ligament stability allow - failed osteotomy

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

kico knee innovation company pty ltd - 33580 - uncoated knee tibia prosthesis, polyethylene - the madison cruciate retaining insert is a fixed or mobile bearing uhmwpe insert with 4 degrees of posterior slope. it attaches to a madison tibial base and articulates with a madison (cruciate retaining) femoral component. the madison cruciate retaining insert is a bearing component of the madison total knee replacement system and is intended to replace the knee joint. the main indications are as follows: - degenerative osteoarthritis or post traumatic arthrosis, in patients whose age, weight, and level of activity are compatible with a satisfactory long term result - rheumatoid polyarthritis - revision of unicompartmental arthroplasty procedure, if bone mass and ligament stability allow - failed osteotomy

United States - English - NLM (National Library of Medicine)

global protection usa, inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic - for handwashing to decrease bacteria on skin without soap and water - recommended for repeated use