Device Dossier
GMK Primary Fixed Tibial Insert STD - Uncoated knee tibia prosthesis, polyethylene
Device Dossier for GMK Primary Fixed Tibial Insert STD - Uncoated knee tibia prosthesis, polyethylene (Uncoated knee tibia prosthesis, polyethylene,…
- GMDN category: Uncoated knee tibia prosthesis, polyethylene
Intended purpose
GMK Standard Fixed 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 Standard 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.