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

microport orthopedics pty ltd - 43168 - non-constrained polyethylene acetabular liner - the subject device is a crosslinked polyethylene acetabular liner. the liner is available in various sizes ranging from 28mm to 36mm (inner diameter) and group b to group g (outer diameter). this liner is used in combination with the procotyl? l acetabular cups. an acetabular liner component of the procotyl l acetabular cup system indicated for use in 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.

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

microport orthopedics pty ltd - 33175 - metallic femoral head prosthesis - the subject device is a femoral head composed of cocr in ?superfinished? polished surface roughness with 12/14 taper. the femoral heads are designed to articulate uhmwpe liners only. 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 - 61271 - femoral stem centralizer - femoral stem centralizer for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. indications include: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 3) inflammatory degenerative joint disease such as rheumatoid arthritis; 4) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed.

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

microport orthopedics pty ltd - 46646 - orthopaedic bone screw, non-bioabsorbable, sterile - cancellous bone screws are intended to be used optionally to enhance the fixation and stabilisation of components used within total knee and total hip arthroplasty.

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.