Device Dossier
Individual Hip Cemented - Uncoated femoral stem prosthesis, one-piece
Device Dossier for Individual Hip Cemented - Uncoated femoral stem prosthesis, one-piece (Uncoated femoral stem prosthesis, one-piece, Class III, sponsor…
- GMDN category: Uncoated femoral stem prosthesis, one-piece
Intended purpose
A Component of a total hip joint prosthesis. The INDIVIDUAL HIP stem is intended to be used for primary and revision total hip arthroplasty. General indications for use include primary or secondary coxarthrosis, femoral head fracture or necrosis, femoral neck fracture, inflammatory arthritis (rheumatoid arthritis etc), major anatomical deformities, congenital hip dislocation,loosening periprosthetic fracture, implant rupture. Specific extra indications for the individual hip are congenital or acquired dysplasia, extreme varus/valgus morphotypes, atypical morphology (dwarfism, gigantism), post-traumatic sequelae, large bone trauma. The INDIVIDUAL HIP cemented femoral stem is intended for revision total hip arthroplasty only. The INDIVIDUAL HIP cementlessfemoral stem is intended for first intention total hip arthroplasty only.
Functional description
The Individual Hip is a patient matched device intended to be a component in a total hip arthoplasty. It requires the use of a modular head and an acetabular cup to complete the construct. The stem has 6 variables covering a number of key parameters giving over 130 million variants to allow precise matching to the patients anatomy. This version of the Individual Hip has a smooth finish and is intended to be cemented into the femoral canal.