Device Dossier
TRIATHLON PKR FEMORAL COMPONENT - Uncoated unicondylar knee femur prosthesis
Device Dossier for TRIATHLON PKR FEMORAL COMPONENT - Uncoated unicondylar knee femur prosthesis (Uncoated unicondylar knee femur prosthesis, Class III,…
- GMDN category: Uncoated unicondylar knee femur prosthesis
- Sponsor: Stryker
Intended purpose
A femoral 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 device designed to replace the bearing surface of one femoral condyle (medial or lateral condyle) of the knee joint. This device is a component of the Triathlon Partial Knee Replacement System which articulates with a tibial insert that is connected to a tibial baseplate. Made of Cobalt Chrome. Intended for use with cement.