Device Dossier
Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular
Device Dossier for Secur-Fit Advanced Hip Stem - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Stryker).…
- GMDN category: Coated hip femur prosthesis, modular
- Sponsor: Stryker
Intended purpose
A component of a total hip joint prosthesis used to replace the femoral the femoral neck. Indications: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and, nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. When used with compatible Howmedica Osteonics Constrained Liners, this device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Functional description
A sterile implantable Femoral Hip Stem designed to replace the proximal femoral neck as part of a Hip Arthroplasty. The proximal region of the stem is coated with PureFix HA over a commercially pure titanium plasma spray substrate. Intraoperatively assembled with a Stryker V40 femoral head and a compatable acetabular component. Intended for cementless use only.