Device Dossier
RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension
Device Dossier for RESTORATION MODULAR FLUTED DISTAL STEM - Body femoral extension (Body femoral extension, Class III, sponsor Stryker). ARTG record,…
- GMDN category: Body femoral extension
- Sponsor: Stryker
Intended purpose
The RESTORATION Modular Hip System is intended for primary and revision total hip arthroplasty as well as in the presence of severe bone loss. These femoral stems are designed to be press fit into the proximal femur. Indications: • Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup); • Correction of functional deformity; • Revision procedures where other treatments or devices have failed; and, • Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Functional description
A sterile distal extension stem designed to connect intraoperatively with a Restoration Modular Femoral Body. When connected together they are designed to replace the proximal femoral neck. Further it is intended to be assembled Intraoperatively with a Femoral Head. Made of Titanium Alloy and intended to be pressfit into the bone without the use of cement.