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

adler ortho australia pty ltd - 35661 - acetabulum prosthesis - the cross-linked pe/pe insert is fitted into the acetabular cup (acetabular shell) and is blocked inside the cup through a locking system present of the acetabular cup in the same group size with which the insert is coupled (i.e. equatorial teeth). it is available in different internal diameters and it articulates with the ceramic femoral head or the co-cr femoral head of the same internal diameter of the insert, permitting to restore the physiological motion of the hip joint. the cross-linked pe/pe insert is designed to be used in total hip arthroplasty (tha), as an articulating surface, and to interface with a ceramic femoral head or a co-cr femoral head, after insertion into an acetabulum prosthesis shell (acetabular cup).

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

adler ortho australia pty ltd - 38156 - ceramic femoral head prosthesis - the delta ceramic femoral head is attached to the trunnion of a femoral stem (or trunnion of a modular neck) through a morse taper available in two sizes (internationally known as 12/14 and 10/12). the femoral head is ball-shaped and it is available in different diameters. each diameter has 3 head center sizes: short, medium, long depending on the head diameter. once coupled with the insert the femoral head permits to restore the physiological motion of the hip joint. the ceramic femoral head is designed to be used in total hip arthroplasty (tha) and to articulate with an acetabulum prosthesis. it can articulate with a ceramic insert or with a pe/crosslinked pe insert.

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

adler ortho australia pty ltd - 48055 - ceramic acetabular liner - the delta ceramic insert is fitted into the acetabular cup (acetabular shell) through a taper connection with outer size in pre-determined groups to match the cup it is chosen to be used with. it is available in different internal diameters and it articulates with the ceramic femoral heads permitting to restore the physiological motion of the hip joint. the ceramic insert is designed to be used in total hip arthroplasty (tha), as the articulating surface to interface with a ceramic femoral head, after insertion into an acetabulum prosthesis shell (acetabular cup).

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

adler ortho australia pty ltd - 43167 - acetabular shell - the fixa ti-por cup is inserted into the pelvic acetabulum using the press-fit principle: the acetabulum is reamed less than the nominal diameter of the cup. the cup is available in different sizes and can accept different types of inserts: ceramic inserts, cross-linked pe/pe inserts, metal inserts. the fixa ti-por cup is designed to be used in total hip arthroplasty (tha) and to be inserted into the pelvic acetabulum without bone cement. the cup is the outer portion of acetabular prosthesis (acetabular shell). internally it can accept a ceramic or pe or metal insert that serves as articulating surface.

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

adler ortho australia pty ltd - 48066 - knee stem - to connect to a femoral or tibial component of a knee joint replacement prosthesis to provide additional stability by extending the attachment of the prosthesis into the mid shaft of the bone and/or to compensate for bone loss depending on individual patient requirements. not intended to provide primary fixation to the bone or operate as an intrinsic element of a joint replacement prosthesis.

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

adler ortho australia pty ltd - 60515 - combination-material acetabulum prosthesis - ti6al4v alloy made directly from powders of titanium, and characterized by three-dimensional ti-por surface designed to improve the primary fixation of the system and to maximize the osseointegration. the insert is pre-assembled to the metallic cup. the titanium alloy outer cup conforms to the shape of the insert, maximizing the contact area and at the same time submitting the internal ceramic core to circumferential compressive stresses that further increase the mechanical strength. agilis ti-por is an uncemented monoblock hemispherical acetabulum designed to articulate with ceramic heads of large diameter. the agilis ti-por system has been designed for all patients whose indication is the cementless implant, with particular reference to cases in which there is a bone tissue with good mechanical quality and to patients with high functional expectations. the surgeon will make the final choice of the system to be used according on his clinical experience and the situation found intra-operatively. indications for use: - primary and secondary arthrosis - rheumatoid and degenerative arthritis - deformities, such as dysplasia - fractures and necrosis of bone - revisions, where other devices or treatments have failed - metastatic diseases

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

adler ortho australia pty ltd - 34198 - coated knee tibia prosthesis - ti6al4v with porous titanium & ha coating. a fixed-bearing tibial component showing a non-anatomical shape and a keel to be anchored to the bone. keel features 2 delta-shaped wings. central part is truncated cone-shaped to anchor tibial stems. locking system for tibial insert - step to be coupled to flexible clips located in the anterior part of tibial insert; posterior part, stair to be coupled with a groove located at the base of tibial insert avoids detachment of components. a tibial component of a tricompartmental fixed-bearing prosthesis to be used in pcl (posterior cruciate ligament) retaining/sacrificing tkr (total knee replacement) for primary and revision surgery. main indications: - primary and secondary arthrosis - rheumatoid arthritis - bone necrosis - revisions, where other devices or treatments have failed

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

adler ortho australia pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - composed of ti6al4v. a fixed-bearing tibial component showing a non-anatomical shape and a keel to be anchored to the bone with bone cement. keel features two delta-shaped wings. central part is truncated cone-shaped, to anchor tibial stems. locking system for tibial insert - a step to be coupled to flexible clips located in the anterior part of the tibial insert; posterior part, a stair to be coupled with a groove located at the base of the tibial insert avoids detachment of the components. a tibial component of a tricompartmental fixed-bearing prosthesis to be used in pcl (posterior cruciate ligament) retaining/sacrificing tkr (total knee replacement) for primary and revision surgery. main indications: - primary and secondary arthrosis - rheumatoid arthritis - bone necrosis - revisions, where other devices or treatments have failed

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

adler ortho australia pty ltd - 59688 - femoral head/stem prosthesis adaptor - the modula neck is manufactured from titanium alloy. the modula? system allows for the independent adjustment of the 3 main parameters: length, offset, version. the 27 points of the tridimensional matrix are covered with the 15 different necks. by combining the matrix positions with the three head options available, the surgeon has 81 different options at his disposal to accurately reconstruct the hip joint geometry. to be used to replace the femoral neck as part of a hip replacement prosthesis. to optimize the reciprocal position of the stem and cup on the basis of the articular needs of the patient, by restoring the physiological offset and length. indicated for use in; primary and secondary arthrosis; rheumatoid and degenerative arthritis, deformities, such as dysplasia; fractures and necrosis of bone; revisions, where other devices or treatments have failed; metastatic diseases

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

adler ortho australia pty ltd - 48069 - uncoated unicondylar knee tibia prosthesis, polyethylene - a cemented single-piece all-poly tibial component of a unicompartmental knee replacement prosthesis composed of uhmw-pe. anterior chamfer to avoid potential patellar conflicts. flat articular surface to facilitate a linear contact with the condyle and better distribute the loading forces. a cemented single-piece tibial component of a medial unicompartmental knee replacement prosthesis. indicated when; ? medial compartment osteoarthritis or avascular necrosis with a well-preserved lateral compartment presenting an intact meniscus and full thickness cartilage. ? normally functioning anterior and posterior cruciate ligaments ? varus deformity able to be passively corrected and in any case lower than 15?. ? flexion contracture less than 15?. ? patello-femoral arthritis is not considered a contraindication. ? age, weight and patient activity level are not considered a contraindication for unicompartmental knee replacement.