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

zimmer biomet pty ltd - 34198 - coated knee tibia prosthesis - cast co/cr/mo alloy one piece, traditional kidney shaped tibial tray with fixed cruciate profile; packaged with ti alloy locking bar. titanium porous plasma spray coating intended for use with or without bone cement. the vanguard xp cruciate retaining (cr) tibial tray porous component is intended for use as part of the vanguard xp knee system, for use with vanguard xp articulations (xp, as) in an intact, functioning pcl total knee. indications for use include: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus or post-traumatic deformity; correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. the titanium porous plasma spray coated cast chrome cobalt molybdenum alloy component is intended for use with or without bone cement.

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

zimmer biomet pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - cast co/cr/mo alloy one piece, traditional kidney shaped tibial tray with fixed cruciate profile; packaged with ti alloy locking bar. intended for cemented use. the vanguard xp cruciate retaining (cr) tibial tray interlok component is intended for use as part of the vanguard xp knee system, with xp or as bearings, for an intact, functioning pcl total knee. indications for use include: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus or post-traumatic deformity; correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. the interlok finish cast chrome cobalt molybdenum alloy component is intended for use with bone cement.

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

zimmer biomet pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - forged co/cr/mo alloy one piece u shaped tibial tray which includes 2 pegs anteriorly and 2 keels posteriorly for fixation to tibia; packaged with ti alloy locking bar. u shape is used for an acl/pcl preserving total knee. intended for cemented use. uhmwpe cement restrictor over locking bar slot must be removed before implantation. the vanguard xp-xp tibial tray interlok component is intended for use as part of the vanguard xp knee system, with xp or as bearings, for an acl/pcl preserving total knee. indications for use include: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus or post-traumatic deformity; correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. the interlok finish forged chrome cobalt molybdenum alloy component is intended for use with bone cement.

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

zimmer biomet pty ltd - 32831 - uncoated knee femur prosthesis - cast cocrmo alloy femoral component with interlok finish. semi-constrained type of knee replacement allows for pcl and acl to remain intact . asymmetric femoral component supports physiologic motion. two modular distal pegs may be removed to allow for attachment of femoral augments in the case of bone deficiencies. the vanguard xp femoral interlok component with pegs is intended for use as part of the vanguard xp knee system for use with vanguard cr, crl, as, xp-xp, xp-as bearings. indications for use include: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus or post-traumatic deformity; correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. the interlok finish chrome cobalt molybdenum alloy component is intended for use with bone cement.

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

zimmer biomet pty ltd - 33745 - coated knee femur prosthesis - cast cocrmo alloy femoral component with ti alloy pps coating. semi-constrained type of knee replacement allows for pcl and acl to remain intact. asymmetric femoral component supports physiologic motion. two modular distal pegs may be removed to allow for attachment of femoral augments in the case of bone deficiencies. the vanguard xp femoral porous component with pegs is intended for use as part of the vanguard xp knee system, for use with vanguard cr, crl, as, xp-xp, xp-as bearings. indications for use include: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; correction of varus, valgus or post-traumatic deformity; correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. the titanium alloy porous plasma spray coated chrome cobalt molybdenum alloy component is intended for use without bone cement.

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

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - the tibial bearing is constructed of dcm arcom uhmwpe. the bearing provides for 15 degrees internal/external rotation, no varus/valgus constraint and includes an enhanced posterior lip. the vanguard cruciate retaining lipped uhmwpe tibial bearing is intended for use in conjunction with biomet tibial trays in both primary and revision applications, with or without bone cement. the indications for use: 1. painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis and/or traumatic arthritis, where one or more compartments are involved. 2. correction of varus, valgus or posttraumatic deformity. 3. correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - the tibial bearing is constructed of e1 antioxidant infused direct compression moulded uhmwpe and articulates with the femoral and tibial tray components in patients requiring posterior cruciate substitution. the posterior stabilised plus bearing provides varus/valgus constraint and rotation resistance. the vanguard e1 posterior stabilised plus uhmwpe tibial bearing is intended for use in conjunction with biomet tibial trays in both primary and revision applications, with or without bone cement, in patients requiring posterior cruciate substitution, with varus/valgus constraint and resistance of internal/external rotation. the indications for use: 1. painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis and/or traumatic arthritis, where one or more compartments are involved. 2. correction of varus, valgus or posttraumatic deformity. 3. correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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

zimmer biomet pty ltd - 34192 - metal-backed patella prosthesis - arcom uhmwpe 3 peg patella implant with cobalt chrome alloy base, and stainless steel wire x-ray markers. the hydroxyapetite coating is intended for cementless fixation. designed for use as a component of a rotating platform total knee prosthesis, with patella sizing determined by femoral component sizing. metal backed arcom uhmwpe patella component of the vanguard rocc rotating platform total knee prosthesis. indications for use: osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments; correction of genu varus, genu valgus or post-traumatic deformities; sequelae of prior procedures. the hydroxyapetite coated metal backed patella is intended for cementless fixation.

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

zimmer biomet pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - cobalt chrome and titanium alloy tibial component with finned stem and highly polished tray to reduce coefficient of friction with tibial bearing. designed for use as a component of a rotating platform total knee prosthesis. nine tibial tray sizes with proportional stems. interlok finish intended for cemented application cobalt chrome and titanium alloy tibial component of the vanguard rotating platform total knee prosthesis. indications for use: osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments; correction of genu varus, genu valgus or post-traumatic deformities; sequelae of prior procedures. the device is intended for cemented fixation

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

zimmer biomet pty ltd - 46585 - prosthesis, knee, internal, insert component - arcom uhmwpe/stainless steel rotating tibial bearing. concave-convex congruency of the prosthesis provides implant stability in all degrees of flexion and offers increased patient comfort. built in 7 degree posterior slope mimics the natural kinematics of the knee. stainless steel x-ray wire embedded in device does not extend beyond the polyethylene arcom uh mw pe and stainless steel tibial insert component of the vanguard rocc rotating platform total knee prosthesis. indications for use: osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments; correction of genu varus, genu valgus or posttraumatic deformities; sequelae of prior procedures.