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

bard australia pty ltd - 33923 - port/catheter, internal, subcutaneous - the m.r.i plastic slimport ultra low profile single lumen implanted port with open-ended polyurethane catheter is a totally implantable vascular access device consisting of an injection port with a self-sealing silicone septum and an open-ended polyurethane catheter. port access is performed by percutaneous needle insertion using a non-coring needle. intended for patient therapies requiring repeated access to the vascular system for infusion of medications, i.v. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

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

zimmer biomet pty ltd - 34190 - uncoated hip femur prosthesis, modular - oss low profile proximal femur features a low profile design for smaller patients with 15 degrees of anteversion. replaces a minimum of 7 cm of the proximal femur. osseoti cylindrical, platform, or conical augments taper fit to the distal portion to promote biological fixation through tissue ingrowth. made from ti-6al-4v alloy. intended for uncemented use. oss low profile proximal femurs are part of the biomet oss orthopaedic salvage system, and is indicated for: 1.painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. correction of varus, valgus, or posttraumatic deformity. 3. correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. ligament deficiencies. 5. tumor resections. 6. treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 7. revision of previously failed total joint arthroplasty. 8. trauma.

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

medical specialties australasia pty ltd - 61494 - vascular port/catheter - the smart port is an implantable venous port designed for power injection. the smart port as a functional unit consists of a small chamber (port housing) with radiopaque catheter. the port is sealed at the top with a self-sealing injection septum. the port body is surgically implanted in a subcutaneous pocket. the smart port includes a complete percutaneous introducer set for surgical implantation. the port is accessed by inserting a non-coring needle (huber needle) into the port septum. the smart port ct low-profile power injectable port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, sampling of blood and power injection of contrast media for imaging.

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

zimmer biomet pty ltd - 34076 - polyethylene acetabulum prosthesis - the mem low profile cup is an acetabular cup component designed to be used in conjunction with a femoral head component for replacement of the acetabulum in total hip arthroplasty. manufactured from sulene? pe, a high-quality conventional polyethylene. the device contains a radiological mark made from cp titanium (protasul?-ti). intended for cemented use only. the mem sulene low profile cup is indicated for patients with noninflammatory degenerative joint disease (nidjd), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (ijd), e.g., rheumatoid arthritis; failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty. total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. this includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the zenith low profile aaa endovascular graft converter is part of a modular system consisting of a main body, main body extension and iliac legs and a converter. it is loaded onto a h&l-b one-shot introduction system and deployed using a trigger wire system. the converter can be used to assist in converting a bifurcated graft into an aortouni-iliac graft if necessary. the main body graft wire guide is used to introduce the converter into the main body. the zenith low profile aaa endovascular graft ancillary component, converter, zlc, is indicated for the treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: ? iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 french (6.0mm od) or 17 french (6.5mm od) vascular introducer sheath; ? non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o with a length of at least 15mm, o with a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm, o with an angle less than 60 degrees relative to the long axis of the aneurysm, and o with an angle less than 45 degrees relative to the axis of the suprarenal aorta. ? iliac artery distal fixation site greater than 10mm in length and 8 to 20 mm in diameter (measured outer wall to outer wall).

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the zenith low profile aaa endovascular graft main body extension can be used to provide additional length to the proximal portion of the endovascular graft. the main body extension utilises a 16fr or 17 fr h&l-b one-shot introduction system which contains a single trigger-wire relese mechanism and deploys the main body extension by sheath retraction and removal of the distal trigger wire. the zenith low profile aaa endovascular graft ancillary component, main body extension, (zlbe), is indicated for the treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: ? iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 french (6.0mm od) or 17 french (6.5mm od) vascular introducer sheath; ? non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o with a length of at least 15mm o with a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm o with an angle less than 60 degrees relative to the long axis of the aneurysm, and o with an angle less than 45 degrees relative to the axis of the suprarenal aorta. ? iliac artery distal fixation site greater than 10mm in length and 8 to 20mm in diameter (measured outer wall to outer wall).

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

johnson & johnson medical pty ltd t/a depuy synthes - 43167 - acetabular shell - the pinnacle deep profile revision acetabular shells with gription are titanium shells coated in gription (titanium sintered particles on a titanium sintered beads substrate) to enable biological (cementless) fixation into the prepared acetabulum. an appropriate liner is then placed into the implanted shell. the deep profile option allows the surgeon to address soft tissue laxity. the device has dome holes and 8 peripheral screw holes. the pinnacle deep profile revision acetabular shell with gription is used in cases of revision of total hip arthroplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

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

johnson & johnson medical pty ltd t/a depuy synthes - 43167 - acetabular shell - the pinnacle deep profile revision acetabular shells with gription are titanium shells coated in gription (titanium sintered particles on a titanium sintered beads substrate) to enable biological (cementless) fixation into the prepared acetabulum. an appropriate liner is then placed into the implanted shell. the deep profile option allows the surgeon to address soft tissue laxity. the device has dome holes and 8 peripheral screw holes. the pinnacle deep profile revision acetabular shell with gription is used in cases of revision of total hip arthroplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

Singapore - engelsk - HSA (Health Sciences Authority)

arthrex singapore, pte. ltd. - orthopaedics - the arthrex low profile screws (2.0‐3.0 mm, solid and cannulated) are intended to be used as stand‐alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non‐unions in the ankle, foot, hand, and wrist. the arthrex low profile screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand‐alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non‐unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur and fibula.

Singapore - engelsk - HSA (Health Sciences Authority)

arthrex singapore, pte. ltd. - orthopaedics - the arthrex low profile screws (2.0‐3.0 mm, solid and cannulated) are intended to be used as stand‐alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non‐unions in the ankle, foot, hand, and wrist. the arthrex low profile screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand‐alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non‐unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur and fibula