Device Dossier
Evolis Standard Insert - Prosthesis, knee, internal, insert component
Device Dossier for Evolis Standard Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
UHMWPE standard tibial insert that forms part of the Evolis Total Knee System, to be used for primary or revision knee arthroplasty, and is designed for tricompartmental replacement of the natural knee joint.
Functional description
A tibial insert manufactured from UHMWPE to be used with a femoral and tibial component in total knee arthroplasty 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.