Device Dossier
METS SMILES, Femoral knee component - Uncoated knee femur prosthesist
Device Dossier for METS SMILES, Femoral knee component - Uncoated knee femur prosthesist (Uncoated knee femur prosthesis, Class III, sponsor Stryker).…
- GMDN category: Uncoated knee femur prosthesis
- Sponsor: Stryker
Intended purpose
The Femoral knee is a component of the METS Smiles Total Knee Replacement which is intended for the replacement of diseased or deficient bone around the knee joint. Indications: • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis • Correction of varus, valgus or post traumatic deformity • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement • Ligament deficiencies • Tumor resections • Revision of previously failed total joint arthroplasty • Trauma
Functional description
The SMILES Femoral knee component is a cobalt-chromium molybdenum femoral component with a titanium stem. Anatomical for left and right sides. Available in small and standard sizes, with 140mm long femoral curved stem Ø13mm for standard components and Ø12mm for small components. A cobalt-chromium molybdenum axle, a pair of pre-assembled UHMWPE bushes and a titanium circlip are packaged with the femoral component.For cemented use.