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

zimmer biomet pty ltd - 43167 - acetabular shell - exceed abt acetabular shell component hip joint replacement prosthesis. made from titanium alloy with porous and hydroxyapatite coating. for cementless applications. for use with biomet e1 bearings utilizing the ringloc-x liner retaining mechanism. multi hole shells are not supplied with titanium-blanking plugs. exceed abt abt multi-hole ringloc-x acetabular shells pc + ha are used in conjunction with other hip prosthesis components to form part of a total hip joint replacement system. the indications for the use include: 1. non-inflammatory degenerative joint diseases including osteoarthritis, avascular necrosis and post-traumatic arthritis. 2. rheumatoid arthritis. 3. correction of functional deformity. 4. revision of failed joint reconstruction or treatment. 5. treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques

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

zimmer biomet pty ltd - 48055 - ceramic acetabular liner - toughened alumina acetabular liner designed to be inserted into corresponding g7 acetabular shell and provide articulating surface for biolox delta or delta option ceramic modular femoral head. toughened alumina acetabular liner intended to provide a ceramic-on-ceramic option to be used in conjunction with biomet?s g7 acetabular shells, biolox delta ceramic femoral heads and biomet?s femoral stem designs with either a type 1 taper or 12/14 taper, as part of a primary or revision total hip joint replacement.

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

zimmer biomet pty ltd - 38156 - ceramic femoral head prosthesis - biolox delta option ceramic modular head components are comprised of a transition-toughened-platelet alumina composite ceramic (ttpa) material with a highly polished surface available in a variety of head sizes. 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 biolox delta option ceramic modular head components are indicated for use either with ceramic acetabular inserts for ceramic on ceramic articulation or with biomet?s range of ultra high molecular weight polyethylene acetabular liners and cups. they may also be used with exceed abt m2a metal inserts for ceramic on metal articulation. indications for use include: 1. non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and post-traumatic arthritis. 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 procedures where other devices or treatments have failed.

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

zimmer biomet pty ltd - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the device is a monoblock glenoid component comprised of a trabecular metal base, and is designed to interface and articulate with zimmer bigliani/flatow? shoulder humeral components for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. manufactured from tantalum (trabecular metal) & ultra-high molecular weight polyethylene (uhmwpe). the device can be press-fit or cemented. indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3 and 4 part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems were arthrodesis or resectional arthroplasty is not acceptable. the assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

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

zimmer biomet pty ltd - 46647 - orthopaedic fixation plate, non-biodegradable - the zimmer trabecular metal ankle fusion spacer and zimmer trabecular metal ankle interpositional spacer are intended for use as an adjunct to an ankle fusion device used in the stabilization of fractures, revision procedures, and joint fusion of the tibia and the talus and where bone voids exist in the ankle.

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

zimmer biomet pty ltd - 33175 - metallic femoral head prosthesis - biomet g7 chrome cobalt modular femoral heads are available with type i and type 12/14 tapers with various neck lengths and are compatible with biomet?s modular femoral stems of the corresponding taper. g7 modular femoral heads are not for metal on metal use biomet g7 cocr alloy modular femoral heads are utilized in conjunction with other hip prostheses components to form part of the g7 total hip joint replacement system. these may be used with mating components indicated for either cemented or uncemented use.

Singapore - engelsk - HSA (Health Sciences Authority)

zimmer pte. ltd. - orthopaedics - the zimmer biomet 12/14 cocr femoral heads are intended for use in total and hemi arthroplasty* in primary and revision patients. *hemi-arthroplasty indication is for use with bipolar systems only.

Singapore - engelsk - HSA (Health Sciences Authority)

zimmer pte. ltd. - orthopaedics - the zimmer biomet 12/14 cocr freedom heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

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

zimmer biomet pty ltd - 33175 - metallic femoral head prosthesis - the biomet endo ii heads are made of cobalt-chrome, and designed to mate with biomet taper type i trunnions, through the use of titanium cylindrical taper adapters. the endo ii head construct is placed on the trunnion of the hip femoral stem and impacted. this hemi-arthroplasty device system is intended to articulate on the patient?s natural acetabulum. the devices are intended to be used in primary applications with biomet cemented or cementless femoral stems. cobalt chrome alloy unipolar femoral head for use with endo ii taper adaptors only in primary hemi hip arthroplasty, intended to relieve pain and restore hip function as a result of disease or accident. indications include: 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 procedures where other treatment or devices have failed

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

zimmer biomet pty ltd - 33175 - metallic femoral head prosthesis - chrome cobalt alloy femoral head designed for use only with freedom constrained acetabular liner. freedom constrained heads are available with type i and type 12/14 tapers with various neck lengths and are compatible with biomet?s modular femoral stems of the corresponding taper. biomet freedom constrained femoral heads are intended for use as a component of a total hip prosthesis in primary and revision patients with a high risk of dislocation due to a previous history, severe joint laxity, and/or palsy of surrounding musculature, bone loss, or intra-operative instability; for whom all other options to constrained acetabular components have been considered. the heads are designed to be used with either a biomet type 1 or type 12/14 femoral taper/stem, and freedom constrained acetabular liners.