Device Dossier

GMRS Small Proximal Tibial Inserts - Prosthesis, knee, internal, insert component

Device Dossier for GMRS Small Proximal Tibial Inserts - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class…

Intended purpose

A tibial insert designed for use with the GMRS small proximal tibial component as part of a Modular Replacement System. 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 GMRS small proximal tibial inserts snap into the GMRS Small Proximal Tibial Component intraoperatively. The inserts are available in five thicknesses and made from Ultra High Molecular Weight Polyethylene (UHMWPE)

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