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

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global ap porocoat humeral stem is made of titanium and is either cemented or cementless. it is coated with porocoat which is intended to improve fixation and stability by promoting bone ingrowth. the global ap porocoat humeral stem is designed to provide fixation within the proximal humerus and a site of attachment for a humeral head prosthesis. the global ap porocoat humeral stem is the humeral component of a total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy.

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

johnson & johnson medical pty ltd t/a depuy synthes - 48088 - humeral head prosthesis - the global advantage humeral head is made of cobalt chrome and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis as part of a shoulder replacement. eccentric heads improve anatomical matching. the global advantage humeral head is the humeral head component of a total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head.

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

johnson & johnson medical pty ltd t/a depuy synthes - 48090 - press-fit shoulder humeral stem prosthesis - the global ap ball taper assembly is made from cocr and is impacted onto the humeral stem. the selected head is then placed onto the impacted ball taper assembly. the ball taper assembly allows for variable geometry of the humeral head (+15? inclination and version) for optimal patient anatomical match. the global ap ball taper assembly is one component of the global ap shoulder system which is intended for total or hemi shoulder arthroplasty. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy.

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

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global advantage porocoat humeral stem is made of titanium and is coated with porocoat. porocoat coated humeral stem prostheses are indicated for cemented or cementless use with fixation provided by biological tissue ingrowth into the porous coating. the global advantage porocoat stem is designed to provide fixation within the proximal humerus and a site of attachment for a humeral head prosthesis. the global advantage porocoat humeral stem is the humeral stem component of total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy.

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

johnson & johnson medical pty ltd t/a depuy synthes - 33710 - partial shoulder prosthesis - the global cap head duofix ha pc is made from cocr with its underside coated in duofix (combination of sintered titanium metal beads and hydroxyapatite) for cementless fixation. the global cap head duofix re-surfaces the humeral head and articulates with either an implanted glenoid component or without a glenoid (hemiarthroplasty). the global cap head duofix ha pc resurfaces the humeral head during total or hemi-shoulder arthroplasty and is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). 4. ununited humeral head fractures. 5. avascular necrosis of the humeral head. 6. rotator cuff tear arthropathy where the rotator cuff is either intact or repairable. 7. deformity and/or limited motion.

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

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global unite reverse fracture epiphyseal body is manufactured from titanium alloy. the device includes porocoat along the proximal circumference and is designed to achieve biological fixation to bone without the use of bone cement on the epiphyseal component, however the device is designed to be affixed to bone with or without bone cement. the global unite reverse fracture epipyseal body is used in conjunction with the global unite shoulder system or the delta xtend reverse shoulder system the global unite reverse fracture epiphyseal body is one component of the global unite shoulder system used in total, hemi, and reverse shoulder arthroplasty. the global unite reverse fracture epiphyseal body in conjunction with existing shoulder systems is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. the device is intended for reverse shoulder arthroplasty in treatment of the following: - fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory - irreducible 3- and 4- part fractures of the proximal humerus - ununited humeral head fractures

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

corin australia pty ltd - 33175 - metallic femoral head prosthesis - the device is intended to be attached to the trunnion end of a prosthetic femoral stem and articulate with the acetabulum or inner surface of an acetabular prosthesis. the device is a replacement femoral head, intended to be attached to the trunnion of a femoral stem prosthesis. the device is manufactured from metal, and is intended to articulate with the acetabulum or the inner surface of an acetabular prosthesis. it is supplied sterile and is intended for single use only.

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

corin australia pty ltd - 38156 - ceramic femoral head prosthesis - the device is intended to be attached to the trunnion end of a prosthetic femoral hip stem, and to articulate with the acetabulum or the inner surface of an acetabular prosthesis. the device is a ceramic femoral head used as the replacement of a diseased or damaged femoral head in total hip arthroplasty, or to revise a previously implanted prosthesis. the device is intended to be attached to the trunnion of a femoral stem prosthesis, and articulate with the acetabulum, or inner surface of an acetabular prosthesis. it is supplied sterile, and is intended for single use only.

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

corin australia pty ltd - 43167 - acetabular shell - the outer shell of a two piece acetabular prosthesis used in hip arthroplasty. the outer surface is porous coated with the addition of ha. the internal surface is covered with a liner that acts as the articulating surface. the device is a metal cup that is used with an internal liner as the acetabular component in total hip arthroplasty, or for the revision of a previous prosthesis. it is supplied in either a three hole or multiple hole configuration. the external surface is porous coated with the addition of ha. the device is supplied sterile, and is intended for single use.

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

corin australia pty ltd - 43168 - non-constrained polyethylene acetabular liner - the inner portion of a two piece acetabular prosthesis. the device provides the articulating surface for the prosthesis, and is used to articulate with the femoral head in a hip arthroplasty the device is the inner part of a two piece acetabular prosthesis. it is manufactured from polyethylene, and is designed to fit into an acetabular cup, and articulate with the femoral head as part of a hip arthroplasty. the device is supplied sterile, and is intended for single use only.