Device Dossier
Delta Multihole TT Acetabular Cup (Ti6AI4V) - Acetabular shell
Device Dossier for Delta Multihole TT Acetabular Cup (Ti6AI4V) - Acetabular shell (Acetabular shell, Class III, sponsor Enovis Surgical). ARTG record,…
- GMDN category: Acetabular shell
Intended purpose
The Delta Multihole Acetabular cup is part of the Delta Revision System indicated for use in total hip arthroplasty for reduction or relief of pain and/ or improved hip function in skeletally mature patients with the following conditions: -Non-inflammatory degenerative joint diseases such as osteoarthritis, avascular necrosis, and hip dysplasia; - rheumatoid arthritis; - post-traumatic arthritis; - correction of functional deformity; - fractures, dislocation of the hip and unsuccessful cup arthroplasty; - revisions in cases of good remaining bone stock; MultiHole TT is also indicated in 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, and hip dysplasia.
Functional description
The Delta MULTIHOLE TT cup is made of Trabecular Titanium™ in order to maximize the primary fixation by press-fit fixation and to assure an effective osseointegration in the shorter time. The Device is characterized by the presence of holes in both the cranial and the caudal position, the numbers of holes varies according to the cup size, and a polar hole which ensures the correct coupling with the insertion wrench, allowing the safe handling and positioning of the device. For cementless use.