Device Dossier
ANATO Hip Stem - Coated hip femur prosthesis, modular
Device Dossier for ANATO Hip Stem - 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
Intended for total hip arthroplasty: • Non inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • 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. Additional indication specific to use of Anato Hip Stem 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 primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. The Anato Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.
Functional description
A sterile implantable Femoral Hip Stem designed to replace the proximal femoral neck as part of a Hip Arthroplasty. Intended for cementless, press-fit application. The proximal region of the stem is coated with PureFix HA over a commercially pure titanium plasma spray substrate. Made of Ti Alloy (Ti6Al4V ELI).