Australia - engelsk - 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 porous?coated humeral stem prostheses are indicated for cemented or cementless use with fixation provided by biological tissue in?growth 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 resectio

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

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global unite anatomic proximal body (epiphyseal) is made from titanium and has a porocoat coating for press-fit or cemented applications. the global unite anatomic proximal body is a modular component that connects to both the global unite stem and global unite humeral head. available in multiple neck shaft angles to allow a surgeon the flexibility to adjust the implant construct to match a patient?s native anatomy. the global unite anatomic proximal body (epiphyseal)is one component of the global unite shoulder system and is intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following: 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.deformity and/or limited motion

Australia - engelsk - 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. 4. deformity and/or limited motion.

Australia - engelsk - 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 135 degree taper assembly is made from titanium and is impacted onto the humeral stem. the selected head is then placed onto the impacted 135 degree taper. the 135 degree taper enables the assembled prosthesis to achieve a fixed 135 degree angle. the global ap 135 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. 4. deformity and/or limited motion.

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

johnson & johnson medical pty ltd t/a depuy synthes - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the global glenoid crosslinked anchor peg is made of crosslinked polyethylene and implantation is intended to be performed with bone cement and bone paste. the global glenoid crosslinked anchor peg achieves immediate stability with the three minimally cemented peripheral pegs, and provides fixation through an interference fit of the central peg. the central peg facilitates bony integration around the flutes for increased fixation strength. the global glenoid crosslinked anchor peg is the glenoid component of a total shoulder joint prosthesis. total 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).

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

johnson & johnson medical pty ltd t/a depuy synthes - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the global shoulder glenoid peg is affixed to the glenoid cavity bone to replace or repair the articulating surface. the device is made of enduron polyethylene and implantation is intended to be performed with bone cement. five pegs (one central and four peripheral) provides stability for the component. the global shoulder glenoid peg is the glenoid component of a total shoulder joint replacement. total shoulder 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).

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

johnson & johnson medical pty ltd t/a depuy synthes - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the global glenoid crosslinked fin is is affixed to the glenoid cavity bone to replace or repair the articulating surface. the device is made of moderately cross-linked polyethylene and implantation is intended to be performed with bone cement and bone paste. the global glenoid crosslinked fin is the glenoid component of total shoulder joint replacement. total 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).

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

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global fx porocoat stem is made of cocr and is coated with porocoat (titanium sintered beads) intended to improve fixation and stability by promoting bone ingrowth. global fx can be used for cemented or cementless applications. global fx provides fixation within the proximal humerus and a site of attachment for a humeral head. the global fx porocoat stem is one 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 i

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

johnson & johnson medical pty ltd t/a depuy synthes - 48089 - humeral head resurfacing 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 duing 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 necro

Australia - engelsk - 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. 4. deformity and/or limited motion.