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

link orthopaedics australia pty ltd - 48069 - uncoated unicondylar knee tibia prosthesis, polyethylene - st. georg tibial plateau polyethylene component for cemented use with the endo-model sled prosthesis system designed to allow for tibial and femoral bone cuts with a minimum of bone removal preserving the hard subchondral bone. the tibial plateaus can be used medially as well as laterally owing to their symmetrical shape. the sizing is adapted to the anatomical shape of the head of the tibia. the structured underside allows a very good interface between implant and bone cement. the st. georg tibial plateau component for use the endo-model sled prosthesis system indicated for treatment minimally invasive knee implant surgical technique for early stages of unicompartmental osteoarthritis of the knee, for intact ligamentous structures and patients with sedentary or light physical activities

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

link medical products pty ltd t/a link pharmaceuticals - hydralazine hydrochloride, quantity: 20 mg - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium hydroxide; propylene glycol - hypertensive crises, especially during late pregnancy (pre-eclampsia and eclampsia).

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

link medical products pty ltd t/a link pharmaceuticals - acetylcysteine, quantity: 2 g - injection, concentrated - excipient ingredients: disodium edetate; water for injections; sodium hydroxide - antidote for paracetamol poisoning. ,acetylcysteine is indicated in the treatment of paracetamol overdose to protect against hepatotoxity.

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

zimmer biomet pty ltd - 43168 - non-constrained polyethylene acetabular liner - this uhmwpe liner comes in a variety of inner diameters, and features a laterialized center of rotation. in 45? of abduction, the liner will move the center of rotation 5mm laterally (increasing offset) and 5mm inferiorly (increasing leg length) in order to provide an additional 7mm in neck length. the liner is locked into the shell component once the metal shell has been secured in the acetabulum. a tivanium alloy locking ring, provided preassembled to the shell, secures the liner to the shell. longevity cross-linked polyethylene liners are part of the trilogy acetabular system that is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (nidjd) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

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

zimmer biomet pty ltd - 43168 - non-constrained polyethylene acetabular liner - the ultra-high molecular-weight polyethylene (uhmwpe) liner is offered in a variety of inner diameters. the device features a neutral (0?) face that provides uniform head coverage. the liner is locked into the shell component once the metal shell has been secured in the acetabulum. a tivanium alloy locking ring, provided preassembled to the shell, secures the liner to the shell. longevity cross-linked polyethylene liners are part of the trilogy acetabular system that is indicated for uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (nidjd) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

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

zimmer biomet pty ltd - 43168 - non-constrained polyethylene acetabular liner - the ultra-high molecular-weight polyethylene (uhmwpe) liner, is offered in a variety of inner diameters. the elevated liners provide optimal femoral head coverage. the liner is locked into the shell component once the metal shell has been secured in the acetabulum. a tivanium alloy locking ring, provided preassembled to the shell, secures the liner to the shell longevity cross-linked polyethylene liners are part of the trilogy acetabular system that is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of non-inflammatory degenerative joint disease (nidjd) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

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

gruppo bioimpianti pty ltd - 43168 - non-constrained polyethylene acetabular liner - inner for fin system made from cross-linked xlpe. it is intended to provide the articulating surface between the acetabulum component (acetabular cup) and the femoral head component of a total hip prostheses system and is used with the cups of the fin system: fin ii cup with ha, fin ii cup, fin mb cup and cups of fin dmd system (fin dmd multihole rev cup, fin dmd ninehole cup and fin dmd cup). inner for fin system cross-linked xlpe is a component of a total hip arthroplasty. the indications are tied to hip pathologies that require an arthroplasty to reduce or eliminate pain and/or improve joint function. the general guidelines are: non-inflammatory degenerative joint disease such as primary of secondary osteoarthritis, aseptic necrosis of the femoral head, rheumatoid arthritis, post traumatic arthritis, correction of functional deformity, outcomes of fractures of the femoral neck, outcomes of traumatic dislocations of the hip, failures of osteotomy and outcomes of arthrodesis.

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

adler ortho australia pty ltd - 33695 - femoral head bipolar component - mobile cross-linked (gamma 75kgy) uhmwpe retentive implant sterilised with ethylene oxide. bipolar insert designed to articulate with fixa duplex dual mobility cups. joint stability is increased by employing a large diameter mobile uhmwpe insert that captures and provides secure articulation of the femoral head whilst also permitting articulation with the outer metal shell. compatible with cocrmo or ceramic heads with diameters of 22.2 mm (all sizes) or 28 mm (from size 48upwards). a sterile bipolar implantable acetabular component of a total hip prosthesis designed to replace the articulating surfaces of the hip in conjunction with an acetabular insert. indicated for; - primary and secondary arthrosis - rheumatoid and degenerative arthritis - deformities, such as dysplasia - fractures and necrosis of bone - revisions, where other devices or treatments have failed - metastatic diseases

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

surgical specialties pty ltd - 44757 - synovial fluid supplementation substance - cingal? is an off-white, opaque, sterile, single-use suspension of a cross-linked ha gel and an ancillary corticosteroid, th. cingal? is biocompatible and non-pyrogenic. the cross-linked ha and th in cingal? do not physically or chemically interact, as micronized particles of the th are suspended in the viscoelastic ha gel and reside in the product as a separate solid phase. cingal? is indicated as a viscoelastic supplement or a replacement for synovial fluid in the knee. cingal? is well suited for rapid and long term relief of the symptoms of knee joint dysfunctions such as osteoarthritis. the actions of cingal? are long term relief of symptoms by lubrication and mechanical support supplemented by short-term pain relief provided by triamcinolone hexacetonide.

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

amplitude australia pty ltd - 43168 - non-constrained polyethylene acetabular liner - the c2 liner is a modular, advanced bearing surface liner, composed of highly cross-linked polyethylene, that minimises wear and increases durability. high tolerance machining and a stable liner locking mechanism provide ease in liner insertion and reduces the potential for wear and particulate debris generation at the cup-liner interface. the c2 cups are the components of a total hip prosthesis. they are intended to be used in primary replacement for total hip arthroplasty and indicated for hip arthroplasty in order to reduce pain and significant disability in cases of: - primitive and secondary hip osteoarthritis; - aseptic osteonecrosis; - rheumatoid arthritis/inflammatory diseases; - hip and acetabular fracture; - hip joint arthroplasty when other devices or treatments have failed.