Device Dossier
Individual Hip TiHA - Press-fit femoral stem prosthesis
Device Dossier for Individual Hip TiHA - Press-fit femoral stem prosthesis (Press-fit femoral stem prosthesis, Class III, sponsor Symbios Orthopaedics).…
- GMDN category: Press-fit femoral stem prosthesis
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 cementless femoral stem implants are intended for first intention total hip arthroplasty only. The INDIVIDUAL HIP cemented femoral stem implants are intended for revision 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 7 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 HA coating and is intended for a press fit application into the femoral canal of the patient