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

microport orthopedics pty ltd - 33175 - metallic femoral head prosthesis - the subject device is a series of cocr femoral head featuring standard polish surface roughness. the implants are designed to be used in combination with any microport orthopedics acetabular cup system. a total hip system component used to replace the femoral head. intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.

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

microport orthopedics pty ltd - 38156 - ceramic femoral head prosthesis - composed of alumina matrix composite, the ceramic femoral head is designed to articulate with dynasty a class poly (uhmwpe) liners. a total hip system component used to replace the femoral head in total hip arthroplasty. 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 conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.

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

microport orthopedics pty ltd - 55834 - press-fit hip femur prosthesis, one-piece - a titanium alloy cementless femoral stem with standard and extended neck options. the stem is coated with plasma spray and includes a driving platform, lateral shoulder, reduced tip and macrofeatures that provide additional rotational stability and maximise compressive loading forces. a total hip system component intended to replace the proximal femur. 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.

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

microport orthopedics pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - a nonporous cocr tibial base device used to replace the proximal tibia of a knee joint in skeletally mature patients. a tibial insert locks into this device, which then articulates with knee femoral components. this device is used with cement. tibial base a component of the advance knee system is intended for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) non inflammatory 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.

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

microport orthopedics pty ltd - 33745 - coated knee femur prosthesis - a cocr femoral knee device designed to articulate with uhmwpe tibial and, if required, uhmwpe patellar prosthetic components of the knee joint.all devices grouped herein are primary, semi-constrained, mp, cocr, porous cocr beaded femurs.these porous-coated femoral components for advance? range in size from 0-6, left and right, and also include ?stature? sizes which are slightly narrower versions of their counterparts designed to fit narrower femoral anatomy.this device is used without cement. a femoral component of the advance knee system is intended for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) non inflammatory 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.

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

microport orthopedics pty ltd - 34203 - uncoated femoral stem prosthesis, modular - the profemur? xm stem is a dual-taper femoral stem made of highly polished forged cocr for cemented use. stems are available in sizes 0-4. included with the femoral stem is a pmma distal femoral stem centralizer, which is used to ensure the stem taper properly engages the cement mantle. a total hip system component intended to repair or replace the proximal femur. 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 conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture.

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

microport orthopedics pty ltd - 34191 - coated femoral stem prosthesis, modular - the profemur? l stems are modular femoral stems, which couple with profemur? modular necks. the stems feature ha coating for cementless implantation. a total hip system component intended to repair or replace the proximal femur. 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.

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

microport orthopedics pty ltd - 59688 - femoral head/stem prosthesis adaptor - cocr modular necks mate in assembly with the appropriate modular femoral stem and femoral head. the modular necks are available in 11 sizes, offering 2 lengths and 6 angles. when combines with five possible femoral head bore sizes, these 11 neck options allow for 100 positions of possible head center location for a single modular stem and a single head diameter. a total hip system component intended to replace the anatomic femoral neck by mating with the prosthetic femoral head and modular femoral stem components. 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 conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.

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

microport orthopedics pty ltd - 32832 - uncoated knee tibia prosthesis, metallic - a nonporous cocr keeled tibial base device used to replace the proximal tibia of a knee joint in skeletally mature patients. it is designed to mate with evolution? tibial inserts and articulate with evolution? femur components. it is asymmetric in design for improved bone coverage and has a enhanced locking mechanism. this device is for cemented use. the tibial base is a component of the evolution medial pivot total knee system used to replace the bearing surface for the distal femoral component. 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.

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

microport orthopedics pty ltd - 46585 - prosthesis, knee, internal, insert component - the cruciate substituting insert locks into the evolution? tibial base. the implant made of uhmwpe is used as a bearing surface upon which the distal femoral component articulates. the evolution? mp cs tibial insert is a component of the evolution? medial pivot total knee system used to replace the bearing surface for the distal femoral component. 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.