Device Dossier
JOURNEY Tibial Baseplate NonPorous - Uncoated knee tibia prosthesis, metallic
Device Dossier for JOURNEY Tibial Baseplate NonPorous - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III,…
- GMDN category: Uncoated knee tibia prosthesis, metallic
- Sponsor: Smith & Nephew
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
A sterile implantable device designed to replace tibial condyles of a knee joint. The tibial base acts as a tray and is designed to hold an insert which articulates with the femoral prosthetic component of the knee joint. The tibia is resected and the implantation of the tibial tray is intended to be performed with bone cement.