Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

evolutis ma australia pty ltd - 34191 - coated femoral stem prosthesis, modular - stemsys hac collarless femoral stem is manufactured from titanium alloy with a single hydroxyapatite layer. the stem is collarless with a micro-grooved 12/14 taper and a cylindrical fully polished neck. features on the stem include metaphyseal bidirectional grooves and diaphyseal vertical grooves. device indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medication and correctly followed conservative treatment have failed. indications for total or partial hip arthroplasty are: - degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip) - inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis) - metabolic hip disease (chondrocalcinosis) - post traumatic degenerative arthritis - avascular necrosis - congenital dysplasia of the hip - functional repair of a recent trauma (fracture, dislocation) - revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty - tumoral surgery when affecting the hip joint

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

evolutis ma australia pty ltd - 34191 - coated femoral stem prosthesis, modular - stemsys hac collared femoral stem is manufactured from titanium alloy with a single hydroxyapatite layer. the stem is collared with a micro-grooved 12/14 taper and a cylindrical fully polished neck. features on the stem include metaphyseal bidirectional grooves and diaphyseal vertical grooves. device indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medication and correctly followed conservative treatment have failed. indications for total or partial hip arthroplasty are: - degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip) - inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis) - metabolic hip disease (chondrocalcinosis) - post traumatic degenerative arthritis - avascular necrosis - congenital dysplasia of the hip - functional repair of a recent trauma (fracture, dislocation) - revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty - tumoral surgery when affecting the hip joint

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

evolutis ma australia pty ltd - 34191 - coated femoral stem prosthesis, modular - stemsys ti+hac collared femoral stem is manufactured from titanium alloy with a dual porous titanium and hydroxyapatite layer. the stem is collared with a micro-grooved 12/14 taper and a cylindrical fully polished neck. features on the stem include metaphyseal bidirectional grooves and diaphyseal vertical grooves. device indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medication and correctly followed conservative treatment have failed. indications for total or partial hip arthroplasty are: - degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip) - inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis) - metabolic hip disease (chondrocalcinosis) - post traumatic degenerative arthritis - avascular necrosis - congenital dysplasia of the hip - functional repair of a recent trauma (fracture, dislocation) - revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty - tumoral surgery when affecting the hip joint

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

evolutis ma australia pty ltd - 34191 - coated femoral stem prosthesis, modular - stemsys ti+hac collarless femoral stem is manufactured from titanium alloy with a dual porous titanium and hydroxyapatite layer. the stem is collarless with a micro-grooved 12/14 taper and a cylindrical fully polished neck. features on the stem include metaphyseal bidirectional grooves and diaphyseal vertical grooves. device indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medication and correctly followed conservative treatment have failed. indications for total or partial hip arthroplasty are: - degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip) - inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis) - metabolic hip disease (chondrocalcinosis) - post traumatic degenerative arthritis - avascular necrosis - congenital dysplasia of the hip - functional repair of a recent trauma (fracture, dislocation) - revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty - tumoral surgery when affecting the hip joint

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

evolutis ma australia pty ltd - 34191 - coated femoral stem prosthesis, modular - stemsys mi is a self-locking, straight and tapered stem with a dual coating of porous titanium and hydroxyapatite, providing anchorage in the proximal femoral metaphysis and an optimal fit and fill of the femoral canal. stemsys mi is a fully coated straight femoral stem made of titanium alloy with a micro-grooved 12/14 taper. the stem features a unique metaphyseal macrostructure oriented along the dynamic load axis. device indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medication and correctly followed conservative treatment have failed. indications for total or partial hip arthroplasty are: - degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip) - inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis) - metabolic hip disease (chondrocalcinosis) - post traumatic degenerative arthritis - avascular necrosis - congenital dysplasia of the hip - functional repair of a recent trauma (fracture, dislocation) - revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty - tumoral surgery when affecting the hip joint

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 33175 - metallic femoral head prosthesis - a sterile implantable ball-shaped component used to replace the anatomical femoral head. intended to fit on the trunnion of a femoral hip stem and articulate with an artificial acetabular component. made of cobalt chrome with a low friction ion treatment (lfit). comes in a range of sizes to suit patient anatomical requirement an implantable ball-shaped component used to replace the anatomical femoral head and intended to attach to the grunion of a femoral stem component used in a total or hemi hip joint replacement. indications: for use as a bipolar hip replacement: ? femoral head/neck fractures or non-unions. ? aseptic necrosis of the femoral head. ? osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. other considerations: ? pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. ? salvage of failed total hip arthroplasty. for use as a total hip replacement: ? painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

exactech australia pty ltd - 38155 - press-fit femoral stem prosthesis - the alteon tapered wedge femoral stem is implanted in the patient's femoral canal, and includes a taper at the end of its neck which mates to a modular femoral head as part of a hip joint replacement. the devices are intended for press-fit, cementless implantation, have a 12/14 taper, and are made from ti alloy with cpti plasma coating. the alteon tapered wedge femoral stems are intended to connect the modular femoral head to the patient's femur as part of a hip joint replacement. the device is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. components of exactech hip systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Austràlia - anglès - 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 (model number l20006) 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.

Austràlia - anglès - 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 collarless femoral stem (model number l20106) 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.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 33175 - metallic femoral head prosthesis - the m-spec 14/16 metal femoral head is made from highly polished orthochrome (cocr) and has a 14/16 taper to attach to a corresponding tapered femoral stem. the m-spec 14/16 metal femoral head can articulate with either a polyethylene acetabular liner or natural acetabulum. the m-spec 14/16 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.