Device Dossier

GMK Primary Fixed Tibial Insert PS - Uncoated knee tibia prosthesis, polyethylene

Device Dossier for GMK Primary Fixed Tibial Insert PS - Uncoated knee tibia prosthesis, polyethylene (Uncoated knee tibia prosthesis, polyethylene, Class…

Intended purpose

GMK Fixed PS Tibial Insert forms part of the GMK Primary Knee System that is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

Functional description

The GMK Primary PS Fixed Tibial Insert is manufactured from UHMWPE and is designed to be used with the GMK Primary femoral and fixed tibial components. The inlay clipping mechanism assures time-effective and safe implantation.

TGA Public Summary