Device Dossier

GMRS PROXIMAL TIBIA COMPONENT - Uncoated knee tibia prosthesis, metallic

Device Dossier for GMRS PROXIMAL TIBIA COMPONENT - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III, sponsor…

Intended purpose

The GMRS proximal tibial component is designed to be used as part of a Modular Replacement System for a total reconstructive replacement of the knee joint. This system is intended for use in patients requiring extensive reconstruction of the hip joint and/or knee joint, including knee fusions, necessitated by extensive bone loss due to trauma, failed previous prosthesis and/or tumor resection. Intended to be implanted with bone cement for the following condition(s): 1. There is destruction of the joint surfaces, with or without significant bone deformity. 2. The cruciate and/or collated ligaments do not stabilize the knee joint. 3. The ligaments are inadequate and/or the musculature is weak. And/or. 4. Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue.

Functional description

The proximal tibial component has a proximal end that flares to a flat surface, having a recess, to allow a tibial insert to snap-in intraoperatively. The proximal portion of the tibial component has suture holes with porous coating to allow tissue re-attachment. Manufactured from cast cobalt-chromium-molybdenum alloy (VITALLIUM Alloy).

TGA Public Summary