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

maxoniq pty ltd - 36042 - prosthesis, internal, joint, temporomandibular, total - intended to reconstruct a damaged or diseased temporomandibular joint that cannot be salvaged. the system consists of fixation screws, custom made mandibular ramus metal alloy condyle, custom made polymer based glenoid fossa component and custom made surgical guides

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

signature orthopaedics pty ltd - 48055 - ceramic acetabular liner - the logical ceramic liner connects to an acetabular shell and provides an articular surface for a femoral head as part of a total hip joint replacement. the device is manufactured from biolox delta ceramic. the logical ceramic liner is intended to replace the articular surface of the patient's acetabulum when used together with an acetabular shell from the signature orthopaedics' hip replacement range, to replace a hip joint where bone stock is sufficient to support the implant. when a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ? non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ? inflammatory joint disease including rheumatoid arthritis (excluding tsi stem) ? correction of functional deformity including congenital hip dysplasia ? traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ? failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

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

signature orthopaedics pty ltd - 43167 - acetabular shell - the acetabular cup is for cementless use and is made of ti6al4v alloy with tps and ha coating and is coupled with a liner. the logical acetabular cup is intended to replace a hip joint where bone stock is sufficient to support the implant and are indicated for: non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis; inflammatory joint disease including rheumatoid arthritis (excluding tsi stem); correction of functional deformity including congenital hip dysplasia; traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture; failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement.

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

signature orthopaedics pty ltd - 43167 - acetabular shell - the acetabular cup is for cementless use and is made of ti6al4v alloy with porous and ha coating and is coupled with a liner. the logical acetabular cup is intended to replace a hip joint where bone stock is sufficient to support the implant and are indicated for: non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis; inflammatory joint disease including rheumatoid arthritis (excluding tsi stem); correction of functional deformity including congenital hip dysplasia; traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture; failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement.

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

mathys orthopaedics pty ltd - 33697 - proximal interphalangeal joint prosthesis, one-piece - intended to replace the approximal interphalangeal joint. replacement following degenerative or inflammatory joint disease, dislocation, sublaxation or pain.

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

mathys orthopaedics pty ltd - 33786 - metacarpophalangeal joint prosthesis - intended to replace a metacarpophalangeal joint. it may be made of metal, ceramic, carbon, polymer or a combination of these. the device may be non-constrained, semi-constrained or constrained and may be designed to be used with or without bone cement.

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

mathys orthopaedics pty ltd - 60459 - proximal interphalangeal joint prosthesis, modular - intended to replace a finger joint. it may be made of metal, ceramic, carbon, polymer or a combination of these. the device may be non-constrained, semi-constrained or constrained and may be designed to be used with or without bone cement.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - amitriptyline hydrochloride - oral solution - 2mg/1ml

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

signature orthopaedics pty ltd - 34076 - polyethylene acetabulum prosthesis - the device is manufactured from cross-linked polyethylene and incorporates a stainless steel ring to allow radiographic identification. geometric design of the articulating face of the cup includes a 20 degree inclination providing more coverage of the femoral head in the superoposterior aspect while maintaining the centre of head rotation with the same centre as the radius of the outer surface of the cup. the evolve ap cup is indicated for use in total hip arthroplasty with pmma bone cement fixation, where bone stock is sufficient to support the implant. indications: - non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - inflammatory joint disease including rheumatoid arthritis (excluding tsi stem) - correction of functional deformity including congenital hip dysplasia - traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

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

signature orthopaedics pty ltd - 33175 - metallic femoral head prosthesis - the evolve unipolar head mates with a femoral stem via taper sleeve adapter, and replaces the articular surface of the patient's natural femoral head as part of a partial hip joint replacement. the device is manufactured from cocr alloy and has a 12/14 taper. the evolve unipolar head is intended to replace the articular surface of the patient's femoral head as part of a partial hip joint replacement. the evolve unipolar head articulates against the patient?s natural acetabulum. the device is indicated for: ? non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ? inflammatory joint disease including rheumatoid arthritis ? correction of functional deformity including congenital hip dysplasia ? traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ? failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement.