Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 34191 - coated femoral stem prosthesis, modular - the corail amt ha size 6 collared femoral stem is made from titanium and coated in hydroxyapatite for cementless fixation into the femoral canal and allows attachment of an appropriate taper femoral head. the full length of the stem has hydroxyapatite coating on the grit blasted surface which induces rapid osteointegration. corail amt ha coated size 6 femoral stems are intended for use in 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, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

perios pty ltd - 38156 - ceramic femoral head prosthesis - the biolox forte alumina femoral head is intended to replace the femoral head in the hip joint. it is made from alumina and available in several diameters, but with a standard 12/14 taper. the ceramic femoral head is intended to be used with ceramic liners and is also compatible with the trianon highly crosslinked polyethylene. the biolox forte alumina femoral head is a sterile prosthetic component designed for first line use, or revision surgery to restore joint function and withstand the usual stresses associated with the hip joint. the prostheses from fh orthopaedics are indicated for use in o primary, dysplasic or protruding coxarthrosis o rheumatoid coxitis o coxarthritis with necrosis of the femoral head o revision surgery in a septic or aseptic environment o congenital dislocation o traumatic injuries o femoral neck fracture o osteonecrosis of the femoral head.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 34191 - coated femoral stem prosthesis, modular - the actis duofix hip femoral stem is manufactured from titanium alloy (ti6al4v) with a titanium bead porous coating (porocoat) and a thin layer of plasma-sprayed hydroxyapatite (ha) coating for cementless fixation. the actis duofix hip femoral stem has a 12/14 taper and is compatible with any modular 12/14 taper femoral head prosthesis. the actis duofix hip femoral stem is intended for use in total hip arthroplasty 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. the actis duofix hip femoral stem is intended for use in hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

amplitude australia pty ltd - 33175 - metallic femoral head prosthesis - cobalt chrome alloy femoral heads are available in multiple neck lengths for proper anatomic fit. heads are highly polished for reduced friction and wear. in revision surgery, the state of the stem neck and the metalback must be assessed. deteriorations such as scratches may have an impact on the functionality and/or stability of the prosthesis. cocr femoral heads can only be combined with polyethylene (pe) liners or acetabular components. amplitude femoral heads are intended for being used as femoral components for replacement of the total hip joint in order to reduce pain and restore hip function in comparison with preoperative status. they need to be associated to femoral stem and acetabular implant. they are indicated in case of hip arthroplasty for the relief of pain and significant disability following: - traumatic injury or non-inflammatory degenerative joint disease of the hip with diagnosis of: - proximal femoral fracture; - acetabular fracture; - non-union of a previously treated fracture; - osteoarthritis; - traumatic arthritis; - avascular necrosis or slipped capital epiphysis; - rheumatoid arthritis/inflammatory diseases. metal femoral heads are also suitable for the revision of hip prostheses and for joint reconstruction.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

amplitude australia pty ltd - 33175 - metallic femoral head prosthesis - a sterile implantable metallic femoral head to substitute for a diseased or injured femoral head. it is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (tha) or with a bipolar component as part of a partial hip arthroplasty. the amplitude metallic stainless steel femoral head is intended for use in a total hip joint replacement

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

djo global pty ltd - 38156 - ceramic femoral head prosthesis - the biolox delta ceramic femoral head is an alumina matrix composite femoral head. it is a component of a total hip joint prostheses. it is intended for use with acetabular liners manufactured from standard ultra high molecular weight polyethylene or highly cross-linked polyethylene. intended for treatment of patients who are candidates for total hip arthroplasty.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

lima orthopaedics australia pty ltd - 38156 - ceramic femoral head prosthesis - the biolox delta is a ceramic 12/14 morse taper femoral head with mechanical and wear resistant capabilities. it is coupled together with a femoral neck. used to replace the anatomical the femoral head and is intended to be attach to the trunnion of a femoral stem component used in a total or hemi hip joint replacement. also used for traumatic/reconstructive joint replacement in orthopaedic procedures.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

lima orthopaedics australia pty ltd - 38156 - ceramic femoral head prosthesis - the biolox delta revision head is an implant that is coupled with an acetabulum component. the head is equipped with a 12/14 morse taper and is made of ceramic and ti6a14v' biolox revision modular head is used to replace the anatomical femoral head and it is intended to be attach to the trunnion of a femoral stem component used in a total or hemi hip joint replacement. also used for traumatic/reconstructive joint replacement in orthopaedic procedures.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 38156 - ceramic femoral head prosthesis - a 12/14 tapered femoral head used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty to fit various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur. manufactured from material biolox delta, an aluminum oxide matrix composite ceramic consisting of approx. 75% alumina (al2o3), 24% zirconia (zro2) and trace elements. the pink color is due to cr2o3. the biolox delta ceramaic femoral heads are modular components used in total hip arthroplasty and indicated for the following: patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patientssuffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 33175 - metallic femoral head prosthesis - a modular femoral component used in conjunction with an acetabular component with an inner articulating surface in total hip arthroplasty. it is made from protasul? -20 [iso 5832-12] composite material. ?noninflammatory degenerative joint disease (nidjd), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (ijd), e.g., rheumatoid arthritis. ? failed previous surgery where pain, deformity, or dysfunction persists. ? revision of previously failed hip arthroplasty. ? total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. this includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.