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

gruppo bioimpianti pty ltd - 33175 - metallic femoral head prosthesis - the cocr femoral head is made of cobalt chromium molybdenum alloy and is intended to be used with a metallic prosthetic femoral stem. the cocr femoral head is available in different diameters each with a 12/14 morse taper of different insert depths so as to axially shift the centre of rotation. the cocr femoral head is a sterile implantable component of the gruppo hip system and is intended to replace the femoral head in total hip arthroplasty to reduce or eliminate pain and/or improve joint function. the indications for use include: - non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - aseptic necrosis of the femoral head - rheumatoid arthritis - correction of functional deformity - outcomes of fractures of the femoral neck - outcomes of traumatic dislocations of the hip - failures of osteotomy - outcomes of arthrodesis

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

gruppo bioimpianti pty ltd - 38156 - ceramic femoral head prosthesis - the biolox delta femoral heads are made of ceramic and are intended to be used with prosthetic femoral stems. the femoral heads are available in three head diameter sizes (28mm, 32mm, 36mm), each with a 12/14 morse taper of four different insert depths so as to axially shift the centre of rotation by -3.5mm, 0mm, +3.5mm, or +7.0mm. the biolox delta ceramic femoral head is a sterile implantable component of the gruppo hip system and is intended to replace the femoral head in total hip arthroplasty procedures. the indications for use include: - non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - aseptic necrosis of the femoral head - rheumatoid arthritis - correction of functional deformity - outcomes of fractures of the femoral neck - outcomes of traumatic dislocations of the hip - failures of osteotomy - outcomes of arthrodesis.

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

gruppo bioimpianti pty ltd - 44054 - surgical procedure kit, orthopaedic, reusable - a selection of various surgical instruments that are used in orthopaedic surgical procedures. the instruments may be provided in a single tray, multiple trays or as a set or kit. some of the instruments may be connected to active medical devices. the sets are provided non sterile. the instruments may be re used following the appropriate cleaning and sterilisation.

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

gruppo bioimpianti pty ltd - 43167 - acetabular shell - the muller cup component is designed to replace or repair the acetabulum of the patient. the muller prosthesis is composed by two components: a principal element made of polyethylene and a stainless steel ring as a radiologic reference. they have a hemispherical shape and are manufactured from uhmwpe. they are cemented cups, with a special grooved design on their convex external surface aimed at improving the cups primary fastening. the muller cup is intended for use in total hip arthroplasty to replace or repair the natural acetabulum. the indications for the use include: - non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - aseptic necrosis of the femoral head - rheumatoid arthritis - correction of functional deformity - outcomes of fractures of the femoral neck - outcomes of traumatic dislocations of the hip - failures of osteotomy - outcomes of arthrodesis

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

gruppo bioimpianti pty ltd - 43167 - acetabular shell - this device is a hemispherical constrained acetabular cup used in hip replacement procedures to reduce pain and restore the hip joint function. it is composed of two components: a main body made of uhmwpe and a stainless steel ring as a radiology reference. the retention design is able to block the head through a particular geometry of the system that resists head dislocation. compatible with 28mm and 32mm heads. for cemented use. the snap-fit cup is a sterile implantable principal component of acetabular component and is intended for use in total hip arthroplasty. the indications for the use include: - non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - aseptic necrosis of the femoral head - rheumatoid arthritis - correction of functional deformity - outcomes of fractures of the femoral neck - outcomes of traumatic dislocations of the hip - failures of osteotomy - outcomes of arthrodesis

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

gruppo bioimpianti pty ltd - 48055 - ceramic acetabular liner - the biolox delta insert component is made of ceramic and intended to be used with the fin ii acetabular cups. the biolox delta insert is available in the 0? (neutral) configuration only, for use with 28mm, 32mm and 36mm femoral heads. it is inserted manually and impacted until firmly in place. the biolox delta ceramic insert is a sterile implantable component that is intended to be used in total hip replacement procedures to replace or repair the articulating surface of a patient?s acetabulum. the indications for the use include: - non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - aseptic necrosis of the femoral head - rheumatoid arthritis - correction of functional deformity - outcomes of fractures of the femoral neck - outcomes of traumatic dislocations of the hip - failures of osteotomy - outcomes of arthrodesis.

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

gruppo bioimpianti pty ltd - 43167 - acetabular shell - the fin ii cup component is designed to replace or repair the acetabulum of the patient. the hemispherical shape allows global contact between cup and acetabular bone. the fin ii cup with ha is manufactured in titanium alloy metal (ti6al4v) and used with a polyethylene, ceramic, or cocr alloy insert liner. the fin ii cup is a sterile implantable principal component of acetabular component and is intended for use in total hip arthroplasty. the indications for the use include: - non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - aseptic necrosis of the femoral head - rheumatoid arthritis - correction of functional deformity - outcomes of fractures of the femoral neck - outcomes of traumatic dislocations of the hip - failures of osteotomy - outcomes of arthrodesis

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

gruppo bioimpianti pty ltd - 33178 - revision uncoated hip femur prosthesis - the modular distal component is a component of the smr modular revision hip stem which is indicated in revision surgery of femoral components. following insertion into the femoral canal the proximal component is inserted into the morse taper of the distal component. a locking screw is inserted into the proximal component and tightened with a t wrench and provides extra anchoring of the distal and proximal components and morse taper. made from titanium. for cementless use. the distal component is a component of the smr stem which is indicated in revision surgery of femoral components, following failure of primary cemented or un-cemented prosthesis with proximal bone loss, enlargement of the medullary canal and thinning of the cortical bone of the proximal femur. revision of a mobilized femoral component, after sub prosthetic or periprosthetic fracture. femoral reconstruction in cases of alterations of bone morphology after fractures or osteotomies.

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

gruppo bioimpianti pty ltd - 33178 - revision uncoated hip femur prosthesis - the modular proximal component is a component of the smr modular revision hip stem which is indicated in revision surgery of femoral components. the proximal component is inserted into the morse taper of the distal component. the proximal component is then impacted and a locking screw inserted. the screw is tightened with a t wrench and screw provides extra anchoring of the distal and proximal components as well as to the morse taper. made from titanium. the proximal component is a component of the smr stem, which is indicated in revision surgery of femoral components, following failure of primary cemented or un-cemented prosthesis with proximal bone loss, enlargement of the medullary canal and thinning of the cortical bone of the proximal femur. revision of a mobilized femoral component, after sub prosthetic or periprosthetic fracture. femoral reconstruction in cases of alterations of bone morphology after fractures or osteotomies.

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

gruppo bioimpianti pty ltd - 46646 - orthopaedic bone screw, non-bioabsorbable, sterile - the fin ii cancellous bone screws are self threading screws used to secure the implantable fin ii acetabular cup in place. the bone screw provides additional fixation to assist in the implantation of the joint replacement. it is used with a slotted head, typically used for internal orthopaedic fracture fixation by being screwed into bone to provide direct interfragmentary stabilization of bone.