Device Dossier

Journey II BCS CoCr Femoral Component - Uncoated knee femur prosthesis

Device Dossier for Journey II BCS CoCr Femoral Component - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Smith &…

Intended purpose

The JOURNEY II BCS Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent. The device is indicated for use only in surgeries where the patella is resurfaced.

Functional description

The JOURNEY II BCS femoral component has a Posterior Stabilized design. It is comprised of tri-compartmental surfaces which are designed to articulate against a non-cross-linked constrained or cross-linked (XLPE) polyethylene tibial insert and a polyethylene patella component, if used. It consists of an anatomically shaped femoral condylar surface with 2 cams located between each condylar surface. The cement interface surface finish is grit blasted and it is intended for cemented fixation only.

TGA Public Summary