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

johnson & johnson medical pty ltd t/a depuy synthes - 38156 - ceramic femoral head prosthesis - the s-rom ceramic femoral head is a ceramic femoral head which affixes to a 11/13 tapered femoral stem and articulates with a 32mm diameter implanted acetabular liner. as part of a total hip arthroplasty, the s-rom ceramic femoral head 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.

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

johnson & johnson medical pty ltd t/a depuy synthes - 33175 - metallic femoral head prosthesis - the articul/eze metal femoral head 22.225mm is made from orthochrome (cocr) and has a 12/14 taper to attach to a corresponding tapered femoral stem. the articul/eze metal femoral head 22.225mm can articualte with a polyethylene acetabular liner. the articul/eze metal femoral head 22.225mm is one component of total or hemi 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 and, for hemi-hip arthroplasty, where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

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

johnson & johnson medical pty ltd t/a depuy synthes - 34191 - coated femoral stem prosthesis, modular - solution femoral stems are made from cocr and have a 12/14 taper to accept a 12/14 tapered femoral head. they are indicated for cementless use with fixation provided by biological tissue ingrowth into the porocoat coating. the solution femoral stem is the femoral component in revision total hip arthroplasty which 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.

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

smith & nephew pty ltd - 34191 - coated femoral stem prosthesis, modular - a porous, hydroxyapatite-coated one-piece titanium alloy femoral component is inserted into a prepared femoral canal following femoral head osteotomy. the femoral canal is rasped with sequential broaches until it reaches the templated stem size. following trial reduction with a broach/trial, standard or high offset neck trial, and femoral head trial, a stem inserter is used to rotate and place the stem. it is seated into the femur with a mallet and a femoral head is impacted on the neck taper. a sterile femoral component of a total hip system. it is designed to mate with either a femoral head or a femoral sleeve and modular head. it is intended to be used in primary total hip replacement and 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.

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

johnson & johnson medical pty ltd t/a depuy synthes - 33175 - metallic femoral head prosthesis - the articul/eze metal femoral head 22.225mm is made from orthochrome (cocr) and has a 12/14 taper to attach to a corresponding tapered femoral stem. the articul/eze metal femoral head 22.225mm can articulate with a polyethylene acetabular liner the articul/eze metal femoral head 22.225mm is one component of total or hemi 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 and, for hemi-hip arthroplasty, where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. 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. porous-coated pinnacle acetabular cups are indicated for cementless applications. hemi-hip arthroplasty is indicated in the following conditions: 1. acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. avascular necrosis of the femoral head. 4. non-union of femoral neck fractures. 5. certain high subcapital and femoral neck fractures in the elderly. 6. degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

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

johnson & johnson medical pty ltd t/a depuy synthes - 34191 - coated femoral stem prosthesis, modular - solution femoral stems are made from cocr and have a 12/14 taper to accept a 12/14 tapered femoral head. they are indicated for cementless use with fixation provided by biological tissue ingrowth into the porocoat coating. the solution femoral stem is the femoral component in revision total hip arthroplasty which 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.

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

zimmer biomet pty ltd - 59688 - femoral head/stem prosthesis adaptor - the versys endo femoral head adaptor is used if a longer neck configuration is needed. the head adaptor is made from zimaloy alloy and employs a 12/14 taper. longer neck lengths are achieved by attaching the corresponding adaptor onto the stem taper. then placing the head on the adaptor. the adaptors are designed not to attach to the standard femoral heads. the versys endoprosthesis femoral head adaptor is a modular component used with the endo femoral head, in hemi-hip arthroplasty, when a longer neck configuration is needed.

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

signature orthopaedics pty ltd - 38156 - ceramic femoral head prosthesis - the signature femoral head (ceramic) mates with a femoral stem via taper connection, and replaces the articular surface of the patient's natural femoral head as part of a total hip joint replacement. the device is manufactured from biolox delta ceramic. the signature femoral head (ceramic) is intended to replace the articular surface of the patient's femoral head as part of a total hip joint replacement, where bone stock is sufficient to support the implant. the device is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital hip dysplasia, traumatic injury of the proximal femur, or failed previous hip surgery.

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

signature orthopaedics pty ltd - 33175 - metallic femoral head prosthesis - the signature femoral head (cocr) mates with a femoral stem via taper connection, and replaces the articular surface of the patient's natural femoral head as part of a total hip joint replacement. the device is manufactured from cocr alloy. the signature femoral head (cocr) is intended to replace the articular surface of the patient's femoral head as part of a total hip joint replacement, where bone stock is sufficient to support the implant. the device is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital hip dysplasia, traumatic injury of the proximal femur, or failed previous hip surgery.

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

smith & nephew pty ltd - 34191 - coated femoral stem prosthesis, modular - a sterile cobalt chrome 12/14 taper femoral stem with a roughcoat porous plus hydroxyapatite coating to the implant tip. the stem has a +15mm calcar platform for use in the presence of a proximal defect of the femur and has double taper proximal geometry to limit shear stresses and to promote compressive stress transfer between the cement and the stem. it is designed with a trapezoidal distal cross section to improve its resistance to rotation and is intended to be used without bone cement. the echelon porous plus ha +15mm calcar femoral component is a femoral stem of a total revision hip system. 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.