Australia - English - 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.

Australia - English - 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

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

zimmer biomet pty ltd - 32835 - prosthesis, internal, joint, shoulder, humeral component - the dual taper insert is a component of the tm reverse shoulder system. this device allows the tm reverse humeral stem to be converted from a "reverse" stem component to a standard stem component. the insert includes 4? morse-type tapers for secure fixation to the humeral head and humeral stem. manufactured from tivanium ti-6al-4v alloy. the tm reverse dual taper insert is indicated for use in hemiarthroplasty/total application as well as reverse application, 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.

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

zimmer biomet pty ltd - 48095 - trabeculated shoulder humeral stem prosthesis - the humeral stem, a component of the tm reverse shoulder system, features a distal fluted stem body & diffusion bonded trabecular metal on the proximal surface of the stem for biological fixation.manufactured from tivanium ti-6al-4v. 6 proximal suture holes & a proximal perimeter rim are positioned to enhance the opportunity for tuberosity & soft tissue reattachment.the proximal stem includes a 4? morse-type taper for secure fixation to the optional spacer.intended for cemented & uncemented use. the tm reverse humeral stem, a component of the tm reverse shoulder system, is indicated for use in hemiarthroplasty/total application as well as reverse application, 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.

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

zimmer biomet pty ltd - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the glenosphere is a component of the tm reverse shoulder system. this device is available in two diameters and includes a 4? morse-type taper for secure fixation to the reverse baseplate. manufactured from zimaloy co-cr-mo alloy. the tm reverse glenosphere is indicated for use in reverse total application, 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.

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

zimmer biomet pty ltd - 33175 - metallic femoral head prosthesis - the zimmer biomet 12/14 cocr freedom heads incorporate a 12/14 taper bore intended to mate with legacy biomet and legacy zimmer 12/14 tapered femoral stems. available in 32mm,36mm head sizes and a variety of neck configurations for use with the corresponding uhmwpe freedom constrained liner and biomet legacy modular acetabular shells. designed with a circumferential flat angled at a 15? angle to the vertical axis to permit easier intraoperative reduction and disengagement during normal activity. the zimmer biomet 12/14 cocr freedom heads are indicated for use in hemi arthroplasty and as a component of a total hip prosthesis in primary and revision patients with an increased risk of dislocation. refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

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

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - zss femoral hinge service kit xt is designed to be used with the distal xt femur and poly insert xt components which have been redesigned to have increased resistance to hyperextension. the femoral hinge service kit xt is 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.

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

zimmer biomet pty ltd - 32831 - uncoated knee femur prosthesis - the zss poly insert is designed to have greater resistance to increased forces with a corresponding projection to the cavity in the xt femoral component. features a raised boss anteriorly that nests into a corresponding recess in the xt distal femur at full knee extension, providing a hyperextension stop with greater polyethylene thickness and larger surface area of contact than existed previously. made with uhmwpe. the polyethylene insert xt is 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.

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

zimmer biomet pty ltd - 32831 - uncoated knee femur prosthesis - the zss distal femur xt is designed to provide increased hyperextension resistance by incorporating a cavity in the femur. a raised boss is featured on the poly insert xt, which nests into the corresponding recess in the femur at full knee extension providing a hyperextension stop. for cemented use. the distal femoral xt is 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.

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

zimmer biomet pty ltd - 39702 - coated shoulder humeral stem prosthesis - humeral stem component for use in hemiarthroplasty including total and reverse applications.? when assembled with a humeral head it may be used for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty.? it is manufactured from tivanium? ti-6al-4v alloy and has a trabecular metal (tantalum) material on the proximal surface which supports biologic ingrowth to facilitate fracture healing. indicated for cemented or uncemented use. indicated for use in hemiarthroplasty/total application as well as reverse application, 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 (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) and where arthrodesis or resectiona