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

microport orthopedics pty ltd - 33175 - metallic femoral head prosthesis - the subject device is a series of cocr femoral head featuring standard polish surface roughness. the implants are designed to be used in combination with any microport orthopedics acetabular cup system. a total hip system component used to replace the femoral head. intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.

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

smith & nephew pty ltd - 34191 - coated femoral stem prosthesis, modular - uncemented cocr straight 12/14 femoral stem with roughcoat porous plus ha and distal flutes. the stem has a standard collar. a circulotrapezoidal neck provides an increased range of motion and a threaded driving platform with an elliptical slot for rotational and axial implant control during insertion. lateral proximal flare improves proximal fill. the rounded lateral shoulder minimises risk of greater trochanter fracture during stem insertion. the distal bullet tip minimises thigh pain. the echelon ha coated straight 190mm standard collar stem is a femoral component 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.

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

smith & nephew pty ltd - 34191 - coated femoral stem prosthesis, modular - uncemented bowed cocr, 12/14 femoral stem with roughcoat porous plus ha and distal flutes. a 15mm calcar platform for proximal femoral defect. a circulotrapezoidal neck provides increased range of motion. threaded driving platform with an elliptical slot for rotational and axial implant control on insertion. lateral proximal flare improves proximal fill. the rounded lateral shoulder minimises risk of greater trochanter fracture during stem insertion. the distal bullet tip minimises thigh pain. the echelon ha coated bowed 260mm + 15mm calcar stem is a femoral component 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.

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

smith & nephew pty ltd - 34191 - coated femoral stem prosthesis, modular - uncemented cocr straight 12/14 femoral stem with roughcoat porous plus ha and distal flutes. a 15mm calcar platform for proximal femoral defect. a circulotrapezoidal neck provides increased range of motion. threaded driving platform with elliptical slot for rotational and axial implant control on insertion. lateral proximal flare improves proximal fill. the rounded lateral shoulder minimises risk of greater trochanter fracture during stem insertion. the distal bullet tip minimises thigh pain. the echelon ha coated straight 190mm + 15mm calcar stem is a femoral component 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.

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

microport orthopedics pty ltd - 33175 - metallic femoral head prosthesis - the subject device is a femoral head composed of cocr in ?superfinished? polished surface roughness with 12/14 taper. the femoral heads are designed to articulate uhmwpe liners only. a total hip system component used to replace the femoral head. intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.

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

zimmer biomet pty ltd - 38156 - ceramic femoral head prosthesis - 44mm, 16/18 taper femoral head component comprised of a transition-toughened-platelet alumina composite ceramic (ttpa) material with a highly polished surface. the highly polished surface is designed to reduce friction and minimize wear. the biolox delta option femoral head component mates with the titanium alloy type 1 or type 12/14 neck sleeve taper adaptor for both primary and revision total hip arthroplasty. only intended for use as ceramic on poly construct. 44mm delta option ceramic head indicated for use as part of total hip replacement construct. when used with g7 acetabular system, this size is only indicated for ceramic on polyethylene use. indications for use include: non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and post-traumatic arthritis; 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 devices or treatments have failed.

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

smith & nephew pty ltd - 34191 - coated femoral stem prosthesis, modular - a cobalt chrome, hydroxyapatite coated femoral stem with a bowed distal geometry to accommodate the natural femoral anatomy. the stem has a 12/14 taper, a circulotrapezoidal neck to provide an increased range of motion and a threaded driving platform with an elliptical slot for rotational and axial implant control during insertion. it is intended to be used without bone cement. the echelon ha coated bowed 260mm standard collar stem is a femoral component 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.

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

smith & nephew pty ltd - 35668 - prosthesis, internal, joint, knee, femoral component - a sterile cobalt-chrome alloy (co-cr) cruciate retaining femoral component with a multiple bead layering of cocr spherical sintered porous beads and a coating of hydroxyapatite coating on the underside for an optimized press-fit. the component is fully coated from the tip of the anterior flange to the edge of the symmetrical posterior condyles. in addition to the porous ha coating, uncoated fixed pegs offer initial medial/lateral stability. the femoral component is impacted into place. indications for use include rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

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

life healthcare pty ltd - 34203 - uncoated femoral stem prosthesis, modular - made of cocrmo, with sandblasted surface for use with bone cement. have the mutars fit (diam 16 mm h7g6) and serration (72 teeth) which allows an adjustment of the antetorsion angle in 5 degree steps. the stem is curved to suit the femur?s physiological antecurvature. it has a hexagonal cross section for rotation stability and collar at the proximal end to prevent subsidence. from length 160mm the stems have 5mm diameter distal bore holes for additional fixation with cortical screws. a femoral stem used in cases of major bone loss to support a hip, knee or diaphysis replacement prosthesis and provide primary fixation to the bone. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis.

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

life healthcare pty ltd - 34191 - coated femoral stem prosthesis, modular - composed of tial6v4 coated with hydroxyapatite (ha). the stems have a hexagonal cross section which provide for an optimal intramedullary fixation. in the femoral area, the stem was designed to correspond with the physiological antecurvation of the femur. hexagonal rasps are used to achieve a primary stability of 70 nm. the stem is to be implanted without bone cement. a femoral stem used in cases of major bone loss to support a hip, knee or diaphysis replacement prosthesis and provide primary fixation to the bone. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis.