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

stryker australia pty ltd - 38156 - ceramic femoral head prosthesis - biolox delta ceramic femoral head is a biocomposite alumina matrix composite (amc) material. a ball-shaped component used to replace the anatomical femoral head and designed for assembly through a taper lock mechanism, to the trunnion of a v40 taper femoral stem. the femoral head comes in a variety of diameters and neck offsets to meet various patient anatomical requirements. an implantable ball-shaped component used to replace the anatomical femoral head and intended to attach to the trunnion of a femoral stem component. indications: ? painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. ? revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ? clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. ? where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum

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

lima orthopaedics australia pty ltd - 33175 - metallic femoral head prosthesis - the accent femoral head is a 12/14 morse taper modular head made of fecrnimnmonbn. the head is placed onto the taper of the neck of the femoral prosthesis and impacted with a femoral head impactor. it is not intended for use with a met-met liner. the accent femoral modular head is indicated for both partial and total hip replacement. femoral modular heads are used in total hip arthroplasty in combination with cemented or uncemented femoral and acetabular components. the main goal of a joint prosthesis is to reproduce the articular anatomy, in part or totally. hip arthroplasty is intended for reductions or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: o non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia; o rheumatoid arthritis; o treatment of femoral head and neck fractures; o revisions in cases of good remaining femoral bone stock;

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

gruppo bioimpianti pty ltd - 38156 - ceramic femoral head prosthesis - the biolox delta femoral heads are made of ceramic and are intended to be used with prosthetic femoral stems. the femoral heads are available in three head diameter sizes (28mm, 32mm, 36mm), each with a 12/14 morse taper of four different insert depths so as to axially shift the centre of rotation by -3.5mm, 0mm, +3.5mm, or +7.0mm. the biolox delta ceramic femoral head is a sterile implantable component of the gruppo hip system and is intended to replace the femoral head in total hip arthroplasty procedures. the indications for use include: - non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - aseptic necrosis of the femoral head - rheumatoid arthritis - correction of functional deformity - outcomes of fractures of the femoral neck - outcomes of traumatic dislocations of the hip - failures of osteotomy - outcomes of arthrodesis.

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

perios pty ltd - 33175 - metallic femoral head prosthesis - the femoral head is made of cobalt-chrome and has a 12/14 taper?. the femoral head is compatible with all fh orthopedics stems. it can be used with uhmwpe and trianon pe acetabular cup and uhmwpe metal-reinforced acetabular cup. the colbalt-chrome femoral head is a component of a hip prosthesis intended for primary, dysplasic or protruding coxarthrosis; rheumatoid coxitis; coxarthrosis with necrosis of the femoral head; revision surgery in a septic or aseptic environment; congenital dislocation; traumatic injuries; femoral neck fracture; ostenonecrosis or the femoral head.

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

johnson & johnson medical pty ltd t/a depuy synthes - 33175 - metallic femoral head prosthesis - the modular m-spec metal femoral head is made from cobalt chrome and is available is 11/13, 12/14 and 14/16 tapers. it press-fits onto a corresponding tapered femoral stem and it articulates with a polyethylene liner or natural acetabulum. the modular m-spec metal femoral head is one component of a total or hemi hip arthroplasty. total and hemi hip arthroplasty is 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. 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 - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 33175 - metallic femoral head prosthesis - the ultamet metal femoral head is made from cobalt chrome and press-fits onto a 9/10 tapered femoral stem. it articulates with a polyethylene liner only. the ultamet metal femoral head is one component of a total or hemi hip arthroplasty. total hip arthroplasty 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. hemi-hip arthroplasty is indicated where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem for 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

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

johnson & johnson medical pty ltd t/a depuy synthes - 33175 - metallic femoral head prosthesis - the articul/eze m-spec metal femoral head is made from highly polished orthochrome (cocr) and has a 12/14 taper to attach to a corresponding tapered femoral head. the articul/eze m-spec metal femoral head articulates with a polyethylene acetabular liner or natural acetabulum. the articul/eze m-spec metal femoral head 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. 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 - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 33695 - femoral head bipolar component - the self centering bi-polar head is a hemi-hip femoral head consisting of a outer cocr cup and an inner uhmwpe insert with plastic retaining ring to be used with a femoral hip stem and modular metal ball with a head diameter corresponding to the inside diameter of the self-centering hip polyethylene insert to replace the femoral head and neck in hemi-hip replacement. self-centering bi-polar head prosthesis is the femoral head component of hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum. 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 - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 38156 - ceramic femoral head prosthesis - the delta ceramic femoral head is made from biolox ceramic (alumina composite) and fixes onto a femoral stem with correpsonding tapered neck. the delta ceramic femoral head is the femoral head 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.

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

smith & nephew pty ltd - 34191 - coated femoral stem prosthesis, modular - a titanium alloy femoral stem with a porous, hydroxyapatite coated surface, circulotrapezoidal neck, and optimized 12/14 taper. the device achieves rotational stability through extended anterior/posterior fins increasing the press-fit. following femoral osteotomy, the femoral canal is sequentially rasped and the calcar is reamed. a trial reduction is then performed. the stem is seated using a stem inserter and mallet. the femoral head is then placed onto the neck taper and impacted. a sterile femoral component of a total hip system. the synergy porous plus ha femoral component is designed to mate with a femoral head and intended to be used without bone cement. it is available in either standard or high offsets.the stems 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.