Device Dossier
TRIATHLON PKR X3 TIBIAL INSERT - Unicondylar knee insert
Device Dossier for TRIATHLON PKR X3 TIBIAL INSERT - Unicondylar knee insert (Unicondylar knee insert, Class III, sponsor Stryker). ARTG record, intended…
- GMDN category: Unicondylar knee insert
- Sponsor: Stryker
Intended purpose
A tibial insert component of a modular unicondylar knee prosthesis that replaces the bearing surfaces of one femoral condyle and corresponding tibial condyle for either left or right knee. Indications: Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis; Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis; As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis; or Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau. These components are intended for implantation with bone cement.
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 on the corresponding condyle. A component of the Triathlon Partial Knee Replacement System intended to replace the bearing surface of one tibial condyle (medial or lateral condyle) of the knee joint. made of X3 polyethylene (highly cross-linked UHWMPE).