Device Dossier

Link Modular Stem Cementless Megasystem C - Knee stem

Device Dossier for Link Modular Stem Cementless Megasystem C - Knee stem (Knee stem, Class III, sponsor Link Orthopaedics). ARTG record, intended…

Intended purpose

The modular stem component of the Modular Bone and Joint Revision System indicated for tumor and revision surgery as an artificial substitute for the knee stem intended to be used 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. * 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 tumors * Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Rotational and Hinge Knee Prostheses)

Functional description

The modular stem component with 12/14 taper of the Modular Bone and Joint Revision System allows partial bone replacements in the proximal and distal femur and total replacement of the femur * Intraoperative flexibility using highly modular implant components * System-integrated components compatible with standard implant systems * Coupling mechanics * Cementless stem components Made from Tilastan TTi6Al4V.

TGA Public Summary