Device Dossier
Unix Uni Knee Femoral Component w/ HA - Coated knee femur prosthesis
Device Dossier for Unix Uni Knee Femoral Component w/ HA - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor Stryker). ARTG…
- GMDN category: Coated knee femur prosthesis
- Sponsor: Stryker
Intended purpose
A Unicompartmental Knee intended for primary or revision joint arthroplasty of the knee. Indications: Moderately disabling joint disease of the knee resulting from painful osteo-or post traumatic arthritis. Revision of previos unsuccessful unicompartmental knee replacement or other procedure. As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
Functional description
A Unicompartmental Knee system consisting of femoral, modular tibial tray and tibial bearing insert, and all-polyethylene tibial components. These femoral components is intended for fixation on the prepared medial or lateral femoral condyle depending on the choice of the appropriate componeent. The femoral component is available in both medial and lateral designs for either the right or left knee. All components are HA coated and are intended for uncemented fixation.