Device Dossier
Insignia - Coated hip femur prosthesis, modular
Device Dossier for Insignia - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Stryker). ARTG record,…
- GMDN category: Coated hip femur prosthesis, modular
- Sponsor: Stryker
Intended purpose
The indications for use of the total hip replacement prostheses include: 1. noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; 2. correction of functional deformity. Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components: When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks Insignia Hip Stems are intended for cementless use only and are intended for total arthroplasty procedures.
Functional description
Insignia Hip Stem is a collared stem that is intended for cementless use in primary applications. It features a plasma-sprayed Hydroxyapatite coating over plasma-sprayed Titanium in the proximal region and a plasma-sprayed Hydroxyapatite coating over grit blast in the distal region and collar underside.