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

zimmer biomet pty ltd - 32831 - uncoated knee femur prosthesis - the resurfacing distal femoral component is utilized for basic reconstruction and larger defects of the distal femur. the implant is available in two options, which replace either 3cm or 5cm of the distal femur. it accepts any of the non-collared oss stems and may be used in conjunction with any of the oss tibial options. made from co-cr-mo and ti-6al-4v alloy. intended for cemented use. oss standard resurfacing femurs are part of the biomet oss orthopaedic salvage system, and is indicated for: 1.painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. correction of varus, valgus, or posttraumatic deformity. 3. correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. ligament deficiencies. 5. tumor resections. 6. treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 7. revision of previously failed total joint arthroplasty. 8. trauma.

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

zimmer biomet pty ltd - 43167 - acetabular shell - titanium alloy acetabular shell multi-hole design with a number of holes increasing with shell diameter, screw holes will not accept screw hole plugs. design facilitates screw placement based on patient anatomy. osseo-ti porous titanium material facilitates tissue ingrowth and implant stability. intended for uncemented biological fixation. shell accommodates multiple bearing options. g7 osseo-ti titanium alloy acetabular shell for use with proper liner, modular head and femoral stem as a component of a total hip prosthesis. intended for both primary and revision applications. indications for use: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 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 treatment or devices have failed. intended for uncemented biological fixation.

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

zimmer biomet pty ltd - 39702 - coated shoulder humeral stem prosthesis - this stem is made of cobalt chrome alloy with titanium alloy porous plasma spray coating at the proximal end, and smooth distal end for cement fixation. two lateral fins with three suture holes and a single medial fin with one suture hole aid tuberosity fixation. comprehensive fracture stems are intended for use with the bio-modular humeral heads and glenoid components and versa-dial humeral heads. stems are 122mm long; available in 2 mm diameter increments comprehensive fracture stem with plasma porous spray as component for use in a total, reverse or partial shoulder replacements. indications for use: 1. non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. rheumatoid arthritis. 3. revision where other devices or treatments have failed. 4. correction of functional deformity. 5. fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. indicated for either cemented or uncemented biological fixation applications.

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

zimmer biomet pty ltd - 48056 - metallic acetabular liner - co-cr-mo acetabular liner compatible with g7 acetabular shells and active articulation bearing heads. secondary motion occurs between the polyethylene bearing and the metal liner when a large range of motion is required in patients with an increased risk of dislocation. intended for uncemented applications. the g7 dual mobility metal liners are part of the g7 dual mobility system. intended for use with either primary or revision hip arthroplasties. indications for use: 1. non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, 2. rheumatoid arthritis., 3. correction of functional deformity, 4. treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques., 5. revision of previously failed total hip arthroplasty, 6. dislocation risks.

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

zimmer biomet pty ltd - 43167 - acetabular shell - the titanium alloy g7 limited hole acetabular shell has a 3 or 4 hole design with apical plug and pre-plugged screw hole. osseo-ti porous plasma spray coating facilitates tissue ingrowth and implant stability. intended for uncemented biological fixation. shell accommodates multiple bearing options. g7 osseo-ti titanium alloy acetabular shell for use with proper liner, modular head and femoral stem as a component of a total hip prosthesis. intended for both primary and/or revision applications. indications for use: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 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 treatment or devices have failed. intended for uncemented biological fixation.

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

zimmer biomet pty ltd - 34036 - orthopaedic cement extraction system - an assembly of reusable devices used for the removal of well-fixed cemented devices in total joint revision procedures. may include slap hammers, chisels, vacuums and powered devices which are intended to be used to break up and remove the bone cement.

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

zimmer biomet pty ltd - 48091 - reverse shoulder prosthesis base plate - titanium alloy mini baseplate with hydroxyapatite coating over porous plasma spray for uncemented biologic fixation; baseplate has 4 identical peripheral locking screw holes for additional fixation; central boss for enhanced fixation and resistance to shear forces. use with biomet comprehensive reverse shoulder system and reverse mini instrumentation. packaged with ti alloy mini taper adaptor. mini baseplate and taper adaptor for the comprehensive reverse shoulder system. indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. the patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

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

zimmer biomet pty ltd - 32831 - uncoated knee femur prosthesis - cobalt chrome femoral component with five design features: rounded sagittal profile; deeper/swept back trochlear groove; extended trochlear groove; wider proximal trochlear groove; ten femoral sizes. extended cam for increased resistance to dislocation in deep flexion. femoral component accepts a variety of stem options and offset adapters. packaged with ti alloy screw; for cemented use. cobalt chrome alloy femoral component of vanguard ssk 360/da 360 revision knee system. indications for use: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus, or post-traumatic deformity; correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - direct compression moulded uhmwpe arcom posterior stabilised constrained tibial bearing size 59. allows for 0.5 degrees of internal/external rotation and 1 degree of varus/valgus lift off. large swept back tibial post to provide stability and continued constraint in deep flexion. large tibial post maintains increased post/box contact. at 90 degrees of flexion, 17 mm of the post remains in the box. direct compression moulded uhmwpe arcom posterior stabilised constrained tibial bearing component of vanguard ssk 360 revision knee system. indications for use: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus, or post-traumatic deformity; correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

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

zimmer biomet pty ltd - 55833 - press-fit hip femur prosthesis, modular - titanium alloy porous coated, bowed, splined, tapered titanium alloy stem. 3 degree splined tapered design transfers load distally and provides rotational stability. grit blast provides for potential long-term stability through bone fixation. packaged with locking screw. titanium alloy pps bowed splined tapered distal femoral stem intended for use as one component of the arcos modular hip revision system. indications for use: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; revision of previously failed total hip arthroplasties. intended for uncemented use only