Device Dossier
Accolade II - Coated hip femur prosthesis, modular
Device Dossier for Accolade II - 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 ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners: • When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in patients at high risk of hip dislocation. ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total hip arthroplasty procedures.
Functional description
The Accolade II Femoral Hip System is a collarless,tapered wedge stem that is intended for cementless,press-fit application. The proximal region of the stem is coated with PureFix HA over plasma spray titanium designed to achieve durable fixation in the proximal femur.