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

zimmer biomet pty ltd - 43167 - acetabular shell - titanium alloy acetabular shell multi-hole design with a number of holes increasing with shell diameter, screw holes will not accept screw hole plugs. design facilitates screw placement based on patient anatomy. osseo-ti porous titanium material facilitates tissue ingrowth and implant stability. intended for uncemented biological fixation. shell accommodates multiple bearing options. g7 osseo-ti titanium alloy acetabular shell for use with proper liner, modular head and femoral stem as a component of a total hip prosthesis. intended for both primary and revision applications. indications for use: 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 by other techniques; revision procedures where other treatment or devices have failed. intended for uncemented biological fixation.

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

zimmer biomet pty ltd - 43167 - acetabular shell - the titanium alloy g7 limited hole acetabular shell has a 3 or 4 hole design with apical plug and pre-plugged screw hole. osseo-ti porous plasma spray coating facilitates tissue ingrowth and implant stability. intended for uncemented biological fixation. shell accommodates multiple bearing options. g7 osseo-ti titanium alloy acetabular shell for use with proper liner, modular head and femoral stem as a component of a total hip prosthesis. intended for both primary and/or revision applications. indications for use: 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 by other techniques; revision procedures where other treatment or devices have failed. intended for uncemented biological fixation.

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

smith & nephew pty ltd - 43167 - acetabular shell - a sterile, stainless steel (m30nw) titanium (cp ti) plasma coated acetabular shell with a high degree of surface roughness to assist in osseointegration. the outside dome of the acetabular shell has a circular feature to ensure correct cup placement and optimal load transfer and the equatorial teeth and ribs prevent rotation and allow for good primary stability. the internal surface of the acetabular shell is highly polished allowing for minimal wear. the acetabular shell is impacted into place. polarcup is indicated for advanced degeneration of the hip joint as a result of osteoarthritis, avascular necrosis, posttraumatic arthritis, or rheumatoid arthritis ? femoral neck fracture or proximal fracture of the hip joint ? conditions resulting from previous operations of the hip joint, such as failed total hip prosthesis

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

orthocentric pty ltd - 43167 - acetabular shell - the orthocentric acetabular shell wedges tightly into the reshaped natural socket and allows new bone to quickly form and grow into its outer surface. additionally, a ceramic or cross-linked polyethylene liner is fitted into the shell. upon implantation, the assembly of these components is designed to replace the natural articulation of the hip joint. mri not tested the orthocentric acetabular shell is a component of an acetabular system (cup) made of two components: an acetabular shell and a liner. it is supplied sterile. the orthocentric acetabular shell is intended for use in total hip arthroplasty. total hip arthroplasty (tha) is indicated for a hip joint replacement in order to provide increased patient mobility and reduce pain where there is evidence of sufficient sound bone to seat and support the components. treatment selection for his patient is the surgeon?s responsibility. when a surgeon has selected total hip arthroplasty as the preferred treatment, the devices are indicated for: - osteoarthritis or post traumatic osteoarthritis - rheumatoid arthritis. - correction of functional deformity. - avascular necrosis of the femoral head or neck. - acute traumatic fracture of the femoral head or neck. - revision of any unsuccessful previous hip surgery or where other treatments or devices have failed. - certain cases of ankylosis. - hip dysplasia (painful or congenital) - severely painful and/or disabled joint the acetabular components are intended for cementless fixation.

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

djo global pty ltd - 43167 - acetabular shell - an acetabular shell designed to accommodate a polyethylene liner insert that serves as the articulating surface. the shell is made from titanium and has a porous coating. it includes multiple holes to allow for fixation with bone screws. intended for treatment of patients who are candidates for total hip arthroplasty.

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

djo global pty ltd - 43167 - acetabular shell - an acetabular shell designed to accommodate a polyethylene liner insert that serves as the articulating surface. the shell is made from titanium and has a porous coating. it includes holes to allow for fixation with bone screws. intended for treatment of patients who are candidates for total hip arthroplasty.

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

djo global pty ltd - 43167 - acetabular shell - an acetabular shell designed to accommodate a polyethylene liner insert that serves as the articulating surface. the shell is made from titanium and has a porous coating. intended for treatment of patients who are candidates for total hip arthroplasty.

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

medacta australia pty ltd - 43167 - acetabular shell - the acetabular shell is metallic and is designed for use in partial or total hip arthroplasty. it is fitted together as a two piece component. the mpact acetabular consists of two individual components, an acetabular shell and an associated liner. the two hole shell allows for the use of bone screws to provide additional fixation. the mpact acetabular shell is designed to be used in total hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint for primary or revision surgery

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

smith & nephew pty ltd - 43167 - acetabular shell - the sterile outer portion of a two-piece cementless acetabulum prosthesis intended to be used with a liner which serves as an articulating surface. the acetabular shell is inserted into a pre-pared acetabulum with an inserter and impacted into place. it may be further affixed with bone screws. 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 degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

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

signature orthopaedics pty ltd - 43167 - acetabular shell - the logical g-series cup shell is implanted in the patient's acetabulum and houses a liner to replace the patient's natural acetabulum as part of a total hip joint replacement. the device is porous coated with ti to provide a surface for bone ingrowth. the device is manufactured from ti6al4v alloy. the device is intended for cementless use only. the logical g-series cup shell is intended to connect a liner to the patient's acetabulum as part of a total hip joint replacement, where bone stock is sufficient to support the implant. when a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ?non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ?inflammatory joint disease including rheumatoid arthritis (excluding tsi stem) ?correction of functional deformity including congenital hip dysplasia ?traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ?failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement