Device Dossier

MRS Cemented Stem Without Porous Body Coating - Knee stem

Device Dossier for MRS Cemented Stem Without Porous Body Coating - Knee stem (Knee stem, Class III, sponsor Stryker). ARTG record, intended purpose, GMDN…

Intended purpose

A stem component of a Modular Replacement System, intended for use in oncology patients requiring extensive reconstruction of the proximal tibia, including the knee joint and knee fusions, necessitated by extensive bone loss due to tumor resection. These prostheses are intended for use with bone cement as a means of intramedullary fixation.

Functional description

A stem component designed to be implanted as part of a Modular Replacement System. The stem is assembled during surgery by impaction causes the taper to securely lock the components together. The modular implants utilize a male/ female taper locking mechanism. Designed to be cemented into the medullay canal. The stem has a body section with a 11mm replacement length. Made of forged Vitallium Alloy.

TGA Public Summary