Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - chrome cobalt molybdenum tibial tray with titanium-niobium-nitrogen (tinbn) coating for allergic patients; packaged with titanium alloy locking bar. components are compatible with femoral elements of the biomet prostheses, provided specific tibial insert is used with same tray fixation system. intended for cemented fixation. finned tibial tray from the biomet modular tibial system. total knee prostheses are designed for use in total knee arthroplasties in the following cases: arthrosis, traumatic arthritis, rheumatoid arthritis, correction of functional deformities and replacement techniques when other treatments have failed. in addition, knee prostheses for allergic patients are appropriate for use in patients who are allergic to any component contained in the chrome-cobalt-molybdenum (cocrmo) alloy, based on astm f-75.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 34198 - coated knee tibia prosthesis - the tibial component of the biomet modular tibial system total knee prosthesis. this cobalt/chrome/molybdenum device has a porous plasma and hydroxyapatite coating and titanium tibial locking bar. the locking mechanism compresses the polyethylene bearing against the tray, thereby reducing micromotion. for cementless use. sterile implantable single use device designed to replace the tibial joint surface during total knee arthroplasty due to arthrosis, traumatic arthritis, rheumatoid arthritis, correction of functional deformity and replacement techniques when other treatments have failed. this is a metallic device intended for use without bone cement and designed to articulate with an insert and a femoral prosthetic component.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 33175 - metallic femoral head prosthesis - co-cr-mo modular femoral head component of biomet hip system. type 1 taper; no skirt; +6mm neck. cobalt chrome modular head component of biomet hip system. indications include: 1. non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 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 using other techniques. 5. revision procedures where other treatment or devices have failed.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - the segmental articular surface is used between the segmental or nexgen rhk distal femoral component and the nexgen rhk proximal tibial component. segmental hinge post is connected to the segmental or nexgen rhk distal femoral component with the hinge pin and set screw and slides through the segmental articular surface and into the nexgen rhk proximal tibial component. articular surface is made from uhmwpe, and the hinge post from co-cr-mo alloy with a pre-installed bushing made of uhmwpe. the segmental articular surface with hinge post is a part of the zimmer segmental system and is indicated for moderate to severe knee instability; significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia; valgus, varus or flexion deformities; the salvage of previously failed surgical attempts.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 34191 - coated femoral stem prosthesis, modular - tm proximal femoral component is designed to replace the proximal femur. available in 38 & 46 mm offsets and 1 resection length. contains suture holes for attaching tissue/bone. made of tivanium? ti-6al-4v alloy with trabecular metal porous coating medially & laterally for biological fixation of tissue/bone. tissue attachment kits may be used to augment tissue/bone fixation in addition to standard suturing.offers solution for attaching both trochanteric bone and/or soft tissue to the prosthesis the tm proximal femoral component is a part of the zimmer segmental system and is indicated for moderate to severe knee instability; significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia; valgus, varus or flexion deformities; the salvage of previously failed surgical attempts.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 60515 - combination-material acetabulum prosthesis - the maxera cup has a monoblock cup construct. biolox? delta ceramic liners, made from an aluminum oxide matrix composite ceramic, are preassembled to lock into the tapered shells? cavity and articulate with biolox heads for ceramic-on-ceramic large diameter head articulation. shell substrate contains tivanium? ti-6al-4v alloy and is coated with a porous ti plasma spray. external surface contains paired fins for supplemental fixation and a ti-vps coating for a scratch fit. uncemented use only. the zimmer maxera cup is used for replacement of the acetabulum in conjunction with a femoral stem and head component in total hip arthroplasty. the zimmer maxera cup is indicated for uncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (nidjd) including but not limited to osteoarthritis, avascular necrosis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (ijd), e.g., rheuma

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 32835 - prosthesis, internal, joint, shoulder, humeral component - poly liner component of the tm reverse shoulder system. designed to be anti-rotational with a groove on the lateral side of the liner to fit around a boss machined on the lateral side of the proximal rim of the humeral implant to prevent rotation. offered as a standard or retentive liner. the retentive liner covers a larger surface area of the glenosphere component, achieved by increasing the included angle of the liner. manufactured from uhmwpe. the tm reverse poly liner is a component of zimmer ? trabecular metal? reverse shoulder system, and is indicated for use in total and reverse applications, in 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, and where arthrodesis or resectional arthroplasty is not acceptable.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - all-poly tibial component of the unicompartmental knee system is designed for the surface reconstruction of individual tibial condyles.stable implant fixation is provided by 2 hourglass-shaped pegs projecting into the tibial bone & by multiple machined islands undercut about their perimeters for cement interdigitation.composed of ultra-high molecular weight polyethylene, except for a 316l stainless steel radiographic indicator wire embedded in the polyethylene.intended for cemented fixation only the zimmer? unicompartmental knee system, all-poly tibial component is an implantable device used to repair or replace the tibial components of a knee joint prosthesis, for patients with: - painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - previous tibial condyle or plateau fractures with loss of anatomy or function. - varus or valgus deformities. it is designed for use when load bearing rom is expected to be less than or equal to 155 degrees.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - proximal tibial component of the zimmer? segmental system replaces the proximal tibia. rotating platform allows the articular surface to rotate 25? in either direction (total rotation of 50?). largely manufactured from zimaloy? co-cr-mo alloy, an uhmwpe bushing extends distally from the proximal articulating surface tray to mate with segmental hinge post. trabecular metal pad allows biologic fixation of tissue, bonded to the lateral side with titanium as a bonding interlayer. for cemented use. the proximal tibial component of the zimmer? segmental system is indicated for moderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of proximal tibia, valgus, varus or flexion deformities, the salvage of previously failed surgical attempts.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the zimmer tm reverse shoulder base plate component is for use in total reverse shoulder arthroplasty. accepts 2 inverse/reverse screws. it is manufactured from tivanium ti-6al-4v alloy with trabecular metal material diffusion bonded to the backside of the baseplate and is intended for cemented or uncemented fixation. the base plate is a component of the zimmer trabecular metal reverse shoulder system 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, and where arthrodesis or resectional arthroplasty is not acceptable.