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

link orthopaedics australia pty ltd - 33178 - revision uncoated hip femur prosthesis - the modular distal femoral replacement components are used to replace the distal femur and is made from cocrmo, uhmwpe and is anatomically adapted. the component can be intra-operatively flexible and used with the megasystem c system through complete compatibility. the distal femoral replacement modular component is part of the endo-model rotational knee system indicated for severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. joint fractures which disallow an osteosynthetic reconstruction; bone necroses; bicondylar arthrosis by partly damaged collateral ligaments; revision surgery after hinge knee or rotational knee joint; revision surgery by insufficient / inadequate bone mass.

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

stryker australia pty ltd - 17846 - catheter, intravascular, guiding - the dac is a single lumen braided shaft variable stiffness catheter with a radiopaque marker on the distal end and a luer hub on the proximal end. the catheter shaft has a hydrophilic coating to reduce friction during use. the distal access catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate distal access catheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. it may be used as a diagnostic angiographic catheter. it is also indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system, including the neurovasculature.

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

djo global pty ltd - 34190 - uncoated hip femur prosthesis, modular - the modular distal centraliser is a component of the foundation hip system. it is made from pmma and is for use with foundation 450 and 460 stems and is for cemented use. the cobra flange and normalisation arches contributes to medial cement compression while improving the resistance to lateral tensile forces. the centraliser assures a cement mantle around the entire femoral stem. a component of a total hip prosthesis intended for treatment of patients who are candidates for total hip arthroplasty. joint replacement is indicated for patients suffering from disability due to: non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis; correction of functional deformity; femoral fracture. this device may also be indicated in the salvage of previously failed surgical attempts.

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - distal extensions used to provide additional length to the endovascular graft distally or to increase the length of overlap between components. it is deployed from an introduction system and a single locking mechanism secures the graft to the introduction until it is released. to facilitate visualisation, gold radiopaque markers are positioned on the ends of the graft. gold markers are placed on stent apices at the proximal and distal graft margins to assist with deployment accuracy. the distal extension is a component of the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: ? iliac/femoral anatomy that is suitable for access with the required introduction systems, ? nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer o with a length of at least 20mm, and o with a diameter measured outer-wall-to-outer-wall of no greater than 42mm and no less than 20mm

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the distal component may be used to extend graft coverage distally. it is fully stented to provide stability and the expansile force necessary to open the lumen of the stent graft during deployment. to assist with alignment, it has an uncovered stent. for added fixation and sealing, it has an internal sealing stent with fixation barbs that protrude through the graft. the distal component is a component of the zenith alpha thoracic endovascular graft which is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: ? iliac/femoral anatomy that is suitable for access with the required introduction systems ? nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer: ? with a length of at least 20mm, and ? with a diameter measured outer-wall-to-outer-wall of no greater than 42 mm and no less than 20mm

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

Singapore - English - HSA (Health Sciences Authority)

indola pharma link singapore pte. ltd. - orthopaedics - aptis medical distal radioulnar head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: . replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: . pain and weakness of the wrist joint not improved by non-operative treatment . instability of the ulnar head with radiographic evidence of dislocation . or erosive changes of the distal radioulnar joint . failed ulnar head resection; eg; darrach resection . primary replacement after fracture of the ulnar head or neck. . revision following failed ulnar head arthorplasty

Singapore - English - HSA (Health Sciences Authority)

zimmer pte. ltd. - orthopaedics - the medial locking plate is indicated for: - pilon fractures: distal tibial intra-articular fractures. - high medial malleolar fractures. - low boot type rotational distal extra-articular shaft fractures while the anterolateral locking plate is indicated for: - distal intra-articular tibia fractures. - proximal tibia fractures. - proximal and distal humerus fractures.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - orthopaedics - it is intended for fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - orthopaedics - it is indicated for the stabilization of fractures of the distal femur.