GMK Sphere Primary E-Cross Tibial Insert Fixed Flex - Bicompartmental knee prosthesis

Intended purpose

Device 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 or unicompartmental 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 Sphere E-Cross tibial insert Flex is manufactured from Vitamin E Highly Crosslinked UHMWPE and is intended to be used to replace the tibial plateau of the knee joint. It is designed to be assembled with a fixed tibial component and to articulate with the GMK-Sphere femoral component. It is mandatory to sacrifice the posterior cruciate ligament.