Device Dossier
EXETER FEMORAL HEAD - Metallic femoral head prosthesis
Device Dossier for EXETER FEMORAL HEAD - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Stryker). ARTG record,…
- 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: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup and Peri-Apatite coated prostheses); 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. 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 forged Stainless Steel. Comes in a range of sizes to suit patient anatomical requirements.