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

permedica australia pty ltd - 43167 - acetabular shell - the traser cup is an acetabular shell component for cementless applications to be used in total hip replacement procedures in combination with an articular liner, a femoral ball-head and a femoral stem. anchorage of the device to the bone is achieved by press-fit insertion. whenever necessary, fixation can be improved by using cancellous bone screws inserted into the dedicated holes. the traser cup is an acetabular shell component for cementless applications to be used in total hip replacement procedures in combination with an articular liner, a femoral ball-head and a femoral stem. indicated in primary and revision hip arthroplasties, all cases of coxarthrosis where the bony tissue of the acetabulum is suitable enough to guarantee a correct and stable primary mechanical press-fit fixation. anchorage of the device to the bone is achieved by press-fit insertion. whenever necessary, fixation can be improved by using cancellous bone screws inserted into the dedicated holes.

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

permedica australia pty ltd - 43168 - non-constrained polyethylene acetabular liner - the vital-xe acetabular liner is a component that locks into the acetabular component and articulars with a femoral ball head on a femoral stem. the articular insert is a cross-linked uhmwpe with vitamin e and is an articular liner for the jump system acetabular cup used in total hip replacement procedures, in primary or revision cases, in combination with a femoral stem and articular ball head.

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

permedica australia pty ltd - 44054 - surgical procedure kit, orthopaedic, reusable - reusable surgical instruments required to perform an orthopaedic surgical procedure.

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

permedica australia pty ltd - 48094 - shoulder prosthesis screw - device intended for implantable shoulder prosthesis assembly and/or fixation. this device is provided sterile.

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

permedica australia pty ltd - 56710 - acetabulum prosthesis apical hole plug - polar plug intended to close the apical hole of a two-price acetabular prosthesis. it is screwed into place after implantation of the acetabular component at the discretion of the surgeon.

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

permedica australia pty ltd - 46646 - orthopaedic bone screw, non-bioabsorbable, sterile - bone screws intended for use when primary stabilisation of the press-fit implant is not considered optimal.

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

permedica australia pty ltd - 55834 - press-fit hip femur prosthesis, one-piece - the exacta s hx-pore stem is manufactured from titanium alloy with a titanium plasm spray and ha coating. the particular shape of the stem avoids excessive bone sacrifice in the trochanteric region. the reduced length allows anchoring in the metaphyseal region with limited involving of the diaphysis. the neck has a reduced cross-section for improved rom. the stem has a 12/14 morse taper and can be used with metal or ceramic femoral heads. the exacta s stem is for use in primary total or partial hip replacement procedures in the following indications: use of the exacta s stems is indicated in the following conditions: avascular necrosis of the femoral head; fractures of the femoral neck/head; rheumatoid arthritis; primary/secondary arthrosis; post-traumatic arthrosis; collagen diseases; displasies and congenital dislocation of the hip joint; epiphyisiolisis; negative outcome of previous surgeries. it is indicated for primary hip arthroplasties in cases where cortical bone structure is suitable enough to guarantee a correct and enduring mechanical fixation by means of press-fit technique.

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

permedica australia pty ltd - 43167 - acetabular shell - the jump system cup is an acetabular component for uncemented applications. anchorage of the device to the bone is by press-fit insertion and fixation can be made more stable by using cancellous bone screws if necessary. the cup is an hemispherical shape with polar deflection; internal conical shape with a retentive anti-rotation circumferential groove; the threaded holes in the cranial region can be sealed with special plugs. the cup is coated with titanium plasma spray with hydroxyapatite. the jump system cup is indicated in primary and revision surgeries, where bone structure is suitable to guarantee a correct and enduring mechanical fixation by means of a press-fit insertion technique, mainly due to: advanced wear of the joint due to dysplasia, degenerative, post-traumatic or rheumatic diseases; fractures or avascular necrosis; negative outcome of previous surgeries such as joint reconstruction, osteotomies; arthrodesis; hemi-arthroplasty or total prosthesis replacement.

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

permedica australia pty ltd - 48055 - ceramic acetabular liner - biolox delta liner with an external conical shape congruent with the inner surface of the cup; fixation to the cup by means of morse-type taper. manufactured from a mix of alumina and zirconia oxide (al2o3 + zro2) and to articulate with a biolox ceramic ball head intended for ceramic on ceramic coupling. biolox delta ceramic insert to be used in primary or revision total hip replacement procedures coupled with a biolox ceramic ball head intended for ceramic on ceramic coupling. indications for use are advanced wear of the joint due to dysplasia, degenerative, post-traumatic, or rheumatic diseases, fractures or avascular necrosis, negative outcome of precedent surgeries such as joint reconstruction, osteotomies, arthrodesis, hemi-arthroplasty or total hip prosthesis.

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

permedica australia pty ltd - 38156 - ceramic femoral head prosthesis - biolox delta ceramic femoral heads are available in 3 neck lengths and are to be used exclusively with polyethylene liners and ceramic biolox inserts. biolox articular heads ensure a very low level of wear thanks to high corrosion resistance, material biocompatibility, degree of hardness, dimensional stability of the components and to excellent wetting and low roughness of surfaces. biolox delta ceramic ball heads are intended to be used in total or partial hip replacement procedures, in combination with a femoral stem providing 12/14 morse-taper, coupling with a bi-articular head or an acetabular cup and related insert (in uhmwpe or biolox forte / biolox delta alumina). indications for use are advanced wear of the joint due to dysplasia, degenerative, post-traumatic, or rheumatic diseases, fractures or avascular necrosis, negative outcome of precedent surgeries such as joint reconstruction, osteotomies, arthrodesis, hemi-arthroplasty or total hip prosthesis.