Device Dossier

Terminal, Oval, Megasystem C - Knee wedge

Device Dossier for Terminal, Oval, Megasystem C - Knee wedge (Knee wedge, Class III, sponsor Link Orthopaedics). ARTG record, intended purpose, GMDN…

Intended purpose

The oval terminal is a component of the Megasystem C Modular Tumour and Revision system and is indicated for mobility-limiting diseases, fractures or defects of the hip joint, the proximal and distal femur through the proximal tibia (only in combination with Endo-Model Rotational and Hinge Knee SL or modular) which cannot be treated by conservative or osteosynthetic procedures. Specifically, revision arthroplasty due to juxta-articular bone defects; Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity; Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture; Deformed proximal femur due to fractures or osteotomies; Correction of bone deficiencies, e.g. due to tumours; Large post-revision and post-trauma segmental bone defects; Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses).

Functional description

The oval terminal component is part of the Megasystem C Modular Tumour and Revision system for partial or total femur replacement. It is made of tilastan and has a height of 10 mm and an inner diameter of 22mm. It is combined with extensions that are used with the push through stem.

TGA Public Summary