Device Dossier
Acetabular augmentation implant
Device Dossier for Acetabular augmentation implant (Acetabular augmentation implant, Class IIb, sponsor Enovis Surgical). ARTG record, intended purpose,…
- GMDN category: Acetabular augmentation implant
Intended purpose
Device indicated for use in total hip arthroplasty and intended for uncemented fixation to the bone. Device intended to be used, in combination with acetabular cups, for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: • non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; • hip dislocation; • rheumatoid arthritis; • post-traumatic arthritis; • correction of functional deformity in case of acetabulum verticalization, anteversion and retroversion; • fractures of femoral neck; • revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; • clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results; • where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.