Device Dossier
TRIATHLON X3 CONDYLAR STABILISING (CS) TIBIAL INSERT - Prosthesis, knee, internal, insert component
Device Dossier for TRIATHLON X3 CONDYLAR STABILISING (CS) TIBIAL INSERT - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…
- GMDN category: Prosthesis, knee, internal, insert component
- Sponsor: Stryker
Intended purpose
The condylar stabilising cruciate retaining tibial insert is a component of the Triathlon total Knee System. General Total Knee Arthroplasty (TKA) Indications include: Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease; Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; Revision of previous unsuccessful knee replacement or other procedure.
Functional description
A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and to articulate with an artificial Femoral Component, to achieve a Total Knee Arthroplasty (TKA). Designed with a patented rotary arc to increase rotation needed for high flexion, a raised anterior lip and a recessed articulating surface which provides anterior constraint, for use with either PCL retaining or sacrificing. Made of X3 polyethylene (highly cross-linked UHWMPE).