אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 46717 - pacing/defibrillation lead stylet - the invicta re-intervention kit is intended to be used with invicta leads only and contains additional accessories required during implantation or re-intervention. the invicta re-intervention kit is intended to be used with invicta leads only and contains additional accessories required during implantation or re-intervention.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 35853 - lead, defibrillator, implantable - the invicta models 1cr and 2cr transvenous tachyarrhythmia leads are true bipolar, steroid eluting, active fixation leads. the leads are designed for implantation with the distal tip positioned in the right ventricle for pacing, sensing, cardioversion and defibrillation therapies. the steroid aims to minimize the inflammatory response and to reduce threshold elevation during the first weeks post-implantation. invicta leads (1cr and 2cr) are right ventricular steroid-eluting defibrillation leads intended for the treatment of life-threatening ventricular arrhythmias when used in conjunction with an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy defibrillator (crt-d). the leads transmit the electrical signal from the myocardium to the icd/crt-d, and deliver electrical impulses and/or shocks to the ventricle for pacing, antitachycardia pacing (atp) and/or defibrillation. the device(s) are mr conditional in the 1.5t and 3t mr environments only.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 48066 - knee stem - a device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 48067 - knee wedge - a device designed to augment the implantation of a knee femur or tibia prosthesis

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 33745 - coated knee femur prosthesis - a cocr femoral knee device with cocr beaded porous coating to replace the distal femur of a knee joint. it is designed to articulate with poly tibial and, if required, poly patellar prosthetic components of the knee joint. all devices grouped herein are primary, semi-constrained, medial-pivot, cobalt chrome, porous cocr beaded, femoral knee components. porous coated components are for use without bone cement. a total knee system component used to replace the distal femur. indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 60516 - metallic acetabulum prosthesis - the procotyl? l acetabular cup is a hemispherical press-fit cup available in 14 sizes ranging from 42mm to 68mm (outer diameter; with 2mm increments between sizes) made from titanium alloy. an irregularly layered porous titanium bead and hydroxyapatite coating enhances initial fixation and long term bone apposition. the cup contains three screw holes located in one quadrant of the cup in additional to the apical hole to allow for surgical flexibility. for a screwless option, hole plugs, includin a total hip system component intended to replace the acetabulum. indications include use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following condition: 1) non-inflammatory degenerative joint disease such as osteoarthritis.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - a hand-held surgical instrument intended to be used for orthopaedic procedures. this is a reusable device.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 34198 - coated knee tibia prosthesis - the subject device is a ti alloy tibial base featuring a biofoam coating on the distal surface. it is designed to mate with the tibial insert and articulate with femur components of the knee joint. the implant features screw holes for additional fixation. a total knee system component used to replace the proximal tibia. indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 34199 - polyethylene patella prosthesis - the subject device is an all polyethylene patellar button used to resurface the patella and articulate with the knee femoral component. the two variants both feature the same articulating surface geometry and differ only by size and thickness. a total knee system component intended to resurface the patella. indications include use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis,; traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 34199 - polyethylene patella prosthesis - the subject device is an all-polyethylene patellar button used to resurface the patella and articulate with the knee femoral component. the subject devices feature 3 pegs for fixation and are available in 6 sizes ranging from 26 to 41mm. a total knee system component intended to resurface the patella. indications include use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis,; traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis.