Device Dossier
Metafix Stem - Coated hip femur prosthesis, modular
Device Dossier for Metafix Stem - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Corin). ARTG record,…
- GMDN category: Coated hip femur prosthesis, modular
Intended purpose
The indications for the Corin MetaFix Hip Stem as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental Dysplasia of the Hip (DDH)and Congenital Dysplasia of the Hip (CDH).It is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Functional description
The MetaFix Hip is a tapered stem manufactured from Titianuim (Ti-6Al-4V) with a layer of hydroxyapatite (HA) Coating applied. The MetaFix Hip is available in a 135º standard offset, 135º lateralised offset and a 125º standard offset in all sizes. The device is intended to be used with 12/14 modular taper heads.