Device Dossier
Metallic femoral head prosthesis
Device Dossier for Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Stryker). ARTG record, intended purpose, GMDN…
- GMDN category: Metallic femoral head prosthesis
- Sponsor: Stryker
Intended purpose
An implantable ball-shaped component used to replace the anatomical femoral head and intended to attach to the trunnion of a femoral stem component used in a total or hemi hip joint replacement. The indications for use for total hip and hemi hip arthroplasty include, noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup and Peri-Apatite coated prostheses), correction of functional deformity, revision procedures where other treatments or devices have failed, treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Functional description
A sterile implantable ball-shaped component used to replace the anatomical Femoral Head. Intended to fit on the trunnion of a Femoral Hip Stem and articulate with an artificial Acetabular Component. Made of Vitallium Alloy. Comes in a range of sizes to suit patient anatomical requirements.