Device Dossier
TRIATHLON X3 POSTERIOR STABILISED (PS) TIBIAL INSERT - Prosthesis, knee, internal, insert component
Device Dossier for TRIATHLON X3 POSTERIOR STABILISED (PS) TIBIAL INSERT - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…
- GMDN category: Prosthesis, knee, internal, insert component
- Sponsor: Stryker
Intended purpose
The PS X3 Tibial Insert is a component of the Triathlon Total Knee System intended for Total Knee Arthroplasty (TKA). Indications include: painful, disabling joint disease of the knee resulting from noninflammatory 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; Ligamentous instability requiring implant bearing surface geometries with increased constraint; Absent or non-functioning Posterior Cruciate Ligament; Severe anteroposterior instability of the knee joint.
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 of the Triathlon Total Knee Arthroplasty (TKA). The post on the Tibial Insert interacts with the femoral component to constrain varus-valgus motion. Made of X3 polyethylene (highly cross-linked UHWMPE).