Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 43167 - acetabular shell - a sterile titanium noncontinuous spherical shell for non-cemented use only with a triple radius profile and a porous titanium plasma and hydroxyapatite coated outer surface. the cup is oversized by 2-3% in the main anchorage area to allow tight contact in the peripheral shell region and a relatively low contact in the pole region. the shell is impacted into place and additional fixation with low profile headed screws may be required in certain circumstances. an acetabular component of the ep-fit plus press-fit cup system. the ep-fit plus shell ti-plasma/ha is intended to be used for the following indications: ? all forms of arthritis ? progressive loss of function of the hip joint as a result of degenerative posttraumatic or inflammatory/rheumatic destruction of the joint ? femoral head necrosis ? fractures in the region of the femoral neck or hip joint ? status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint replacement

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 43167 - acetabular shell - constructed of cpti (sulmesh?-ti, protasul?-ti), the fitmore shell is a modular metal back acetabular shell that is used in combination with a specific liner and femoral head to provide an articulating surface. it utilises the press-fit concept and has a pair of triangular, self-tapping stabilising fins for mechanical stability. fitmore shells used with a compatible insert are indicated for uncemented use as the acetabular component in total or hemi hip arthroplasty for replacing the hip joint of patients suffering severe pain or disability, e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (ijd), rheumatoid arthritis; patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty provided there is an adequate bone stock to support the cementless fixation of the acetabular shell.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 43167 - acetabular shell - a sterile hemispherical acetabular porous-coated shell with non-animal derived hydroxyapatite to enhance stability. the shell may present with 0 or 3 holes. prior to the insertion of the polyethylene liner, the apex hole is covered with a watertight threaded hole cover and any unused screw holes, if applicable are covered with hole cover which are impacted into place. a titanium alloy porous coated plus ha acetabular shell being the outer portion of a two-piece acetabulum prosthesis intended to be used without bone cement. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

amplitude australia pty ltd - 43167 - acetabular shell - the horizon ii cup with holes is a hemispherical acetabular cup with flat pole and has an equatorial press fit with inverted grooves (chevron configuration) for anti-rotation, antiprotrusion and anti?back out. the cup is double coated with sprayed titanium and ha. 5 holes in the upper face ensuring secondary fixation by screws embedded in the acetabular cup, preventing any contact with the insert. the horizon ii acetabular shell is intended to be used in hip joint conditions due to degenerative or congenital, inflammatory, or post-traumatic causes and sequelae from previous interventions, total hip replacement, osteotomy, arthrodesis.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 43167 - acetabular shell - the pinnacle 300 acetabular shell with porocoat are titanium shells coated in porocoat (titanium sintered beads) to enable biological fixation into the prepared acetabulum. three coated spikes located on the radius support for additional fixation. an appropriate liner is then placed into the implanted shell. the pinnacle 300 acetabular shell with porocoat is an acetabular shell used during primary or revision total hip arthroplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 43167 - acetabular shell - the pinnacle revision acetabular shells with gription are titanium shells coated in gription (titanium sintered particles on a titanium sintered beads substrate) to enable biological fixation into the prepared acetabulum. the pinnacle revision acetabular shells with gription is intended for cementless applications and includes additional peripheral screw holes. an appropriate liner is then placed into the implanted shell. the pinnacle revision acetabular shell with gription is used in cases of revision of total hip arthroplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 43167 - acetabular shell - acetabular shell component of hip joint replacement prostheses. press fit cementless shell made from titanium alloy with a porous coating. solid shell configuration eliminates potential channels for polyethylene wear debris to migrate into peri-prosthetic tissue. six to eight anti rotational tabs on the shells rim create an interference fit with the notches on the polyethylene liner to provide maximum rotational stability. ringloc hemispherical solid shell porous coated is intended for use in total hip arthroplasty. indications include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. correction of functional deformity. treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. revision procedures where other treatment or devices have failed.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 43167 - acetabular shell - the pinnacle acetabular 100 shells with porocoat are titanium shells coated in porocoat (titanium sintered beads) to enable biological fixation into the prepared acetabulum. an appropriate liner is then placed into the implanted shell. the pinnacle 100 acetabular shell with porocoat is an acetabular shell used during primary or revision total hip arthoplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 43167 - acetabular shell - the pinnacle 100 acetabular shells with duofix are titanium shells coated in duofix (combination of sintered titanium metal beads and hydroxyapatite) to enable biological fixation into the prepared acetabulum. an appropriate liner is then placed into the implanted shell. the pinnacle 100 acetabular shell with duofix is an acetabular shell used during primary or revision total hip arthoplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 43167 - acetabular shell - the pinnacle sector acetabular shells with duofix are titanium shells coated in duofix (combination of sintered titanium metal beads and hydroxyapatite) to enable biological fixation into the prepared acetabulum. these shells are indicated for cementless applications. additionally, the pinnacle sector acetabular shells with duofix have three screw holes for optional adjunct fixation and access to the ilium and posterior column. an appropriate liner is then placed into the implanted shell. the pinnacle sector acetabular shell with duofix is an acetabular shell used during primary or revision total hip arthoplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.