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

zimmer biomet pty ltd - 36259 - prosthesis, internal, joint, shoulder, glenoid component - modular hybrid glenoid base component shoulder joint replacement prostheses. made from uhmwpe/ti-6al-4v alloy. available in three base sizes with three variations in glenoid fixation. non-conforming diameter of curvature provides the ability to use any size head with any size glenoid. if the device is used with the optional porous titanium peg bone cement should not be used. if using the optional polyethylene peg it should be inserted with bone cement. the modular hybrid glenoid base is part of the comprehensive shoulder system and is intended for partial or total shoulder joint arthroplasty. indications for use include: non?inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. fractures of the proximal humerus, where other methods of treatment are deemed inadequate. difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

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

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - the tibial bearing is constructed of e1 antioxidant infused direct compression moulded uhmwpe and articulates with the femoral and tibial tray components. the posterior stabilised standard bearing does not constrain the femur in rotation or varus/valgus lift-off. the vanguard e1 posterior stabilised uhmwpe tibial bearing is intended for use in conjunction with biomet tibial trays in both primary and revision applications, with or without bone cement. the indications for use: 1. painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis and/or traumatic arthritis, where one or more compartments are involved. 2. correction of varus, valgus or posttraumatic deformity. 3. 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 - the tibial bearing is constructed of e1 antioxidant infused direct compression moulded uhmwpe and articulates with the femoral and tibial tray components. the bearing provides for 15 degrees internal/external rotation, no varus/valgus constraint and includes an enhanced posterior lip. the vanguard e1 cruciate retaining lipped uhmwpe tibial bearing is intended for use in conjunction with biomet tibial trays in both primary and revision applications, with or without bone cement. the indications for use: 1. painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis and/or traumatic arthritis, where one or more compartments are involved. 2. correction of varus, valgus or posttraumatic deformity. 3. 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 - 36259 - prosthesis, internal, joint, shoulder, glenoid component - glenoid base fixation peg shoulder joint replacement prosthesis. compression fit central peg has fins that interfere with a prepared hole in the centre of the glenoid. requires bone cement at the base of the central peg. made from titanium alloy (ti-6al-4v) and arcom uhmwpe. for use with the modular hybrid glenoid base. the pc hybrid glenoid post is intended for use as a component of a shoulder replacement prosthesis. indications include: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. fractures of the proximal humerus, where other methods of treatment are deemed inadequate. difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

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

zimmer biomet pty ltd - 36259 - prosthesis, internal, joint, shoulder, glenoid component - glenoid base fixation peg shoulder joint replacement prosthesis. the regenerex central peg has a porous titanium coated surface for biologic fixation and does not require bone cement. for use with the modular hybrid glenoid base. the pt hybrid glenoid post is intended for use as a component of a shoulder replacement prosthesis. indications include: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. fractures of the proximal humerus, where other methods of treatment are deemed inadequate. difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

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

zimmer biomet pty ltd - 39702 - coated shoulder humeral stem prosthesis - intramedullary humeral stem with for fixation into the remaining humeral bone. made from ti-al-4v alloy. the terminal portion is porous coated for biological fixation in shoulder applications and cement adherence in both proximal humeral and elbow applications. the distal portion is grit blasted. the stems, proximal bodies, intercalary segments and distal bodies connect to each other via a taper junction and locking screws. the ti-6al-4v modular stem is part of the comprehensive segmental revision system. it is designed to create a proximal, distal and total humeral replacement and can be used in total or partial shoulder replacements when used with components from the comprehensive total shoulder system and bio-modular shoulder system. indications for use include: non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. oncology applications including bone loss due to tumor resection.

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

zimmer biomet pty ltd - 39702 - coated shoulder humeral stem prosthesis - intramedullary humeral stem for fixation into the remaining humeral bone. made from co-cr-mo. the terminal portion has a porous ti-al-4v alloy coating for biological fixation in shoulder applications and cement adherence in both proximal humeral and elbow applications. the distal portion is grit blasted. the stems, proximal bodies, intercalary segments and distal bodies connect to each other via a taper junction and locking screws. the cocr modular stem is part of the comprehensive segmental revision system. it is designed to create a proximal, distal and total humeral re placement and can be used in total or partial shoulder replacements when used with components from the comprehensive total shoulder system and bio-modular shoulder system. indications for use include: non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. oncology applications including bone loss due to tumor resection.

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

zimmer biomet pty ltd - 60511 - reverse shoulder prosthesis body - titanium humeral tray component, reverse shoulder joint replacement prosthesis. an expanding ring locks around the humeral bearing. six suture slots provide attachment points. compatible with all humeral bearings and glenospheres. the humeral tray is made from ti-6al-4v alloy and the locking ring is made from cp titanium. comprehensive reverse shoulder titanium humeral tray is intended for use as a component of a shoulder replacement prosthesis. indications include 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.

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

zimmer biomet pty ltd - 60511 - reverse shoulder prosthesis body - cobalt chrome humeral tray component, reverse shoulder joint replacement prosthesis. an expanding ring locks around the humeral bearing. six suture slots provide attachment points. compatible with all humeral bearings and glenospheres. the humeral tray is made from co-cr-mo alloy and the locking ring is made from cp titanium. comprehensive reverse shoulder cobalt chrome humeral tray is intended for use as a component of a shoulder replacement prosthesis. indications include 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.

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

zimmer biomet pty ltd - 48088 - humeral head prosthesis - comprehensive shoulder system standard taper adaptor. made from titanium alloy. the adaptor has two male tapers (one mates with the head, one mates with the stem), which are offset from each other. this allows the head to have variable offset. use with biomet comprehensive shoulder system. taper adaptor for use as a component of the comprehensive shoulder system. indications include: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. rheumatoid arthritis. revision where other devices or treatments have failed. correction of functional deformity. fractures of the proximal humerus, where other methods of treatment are deemed inadequate. difficult clinical management problems, including cuff arthropathy, where other methods of treatment are deemed inadequate.