Device Dossier

GENESIS II HA Coated Porous Posterior Stabilized Femoral - Coated knee femur prosthesis

Device Dossier for GENESIS II HA Coated Porous Posterior Stabilized Femoral - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III,…

Intended purpose

The GENESIS II HA Coated Porous Posterior Stabilised Femoral is a cobalt-chrome alloy component of the GENESIS II Total Knee System, intended for uncemented use. Indications for use include rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement or total knee replacement. Posterior stabilised knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

Functional description

A CoCr femoral component with open box design to replace the femoral condyles during knee joint replacement. The device articulates with a posterior stabilised (PS) tibial insert and, if required, patellar prosthetic components of the knee joint. The internal surface of the femoral component has a sintered CoCr bead and hydroxyapatite coating. Flex-Lok pegs or finned lugs may be added for stability and increased pullout strength. It is intended to be used without bone cement

TGA Public Summary