Device Dossier
PFC Sigma Modular Tibial Tray - Uncoated knee tibia prosthesis, metallic
Device Dossier for PFC Sigma Modular Tibial Tray - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III, sponsor…
- GMDN category: Uncoated knee tibia prosthesis, metallic
Intended purpose
The PFC Sigma Modular Tibial Tray - CoCr is the tibial resurfacing component which holds the insert component of a total knee arthroplasty. It is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant.
Functional description
The PFC Sigma Modular Tibial Tray - CoCr is designed to replace the tibial condyles during bicondylar replacement of the knee joint and is made of CoCr with a highly polished top surface. The i2 locking mechanism locks in the tibial insert which decreases micro-motion. Implantation is intended to be performed with bone cement.