Device Dossier

BioBall™ Delta Ceramic Head - Ceramic femoral head prosthesis

Device Dossier for BioBall™ Delta Ceramic Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Enovis Surgical).…

Intended purpose

The BioBall™ Delta Head is part of the BioBall™ System intended for use in total hip arthroplasty in patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, Avascular necrosis of the femoral head, Correction of functional deformity, Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques and for revision procedures where other treatment or devices have failed.

Functional description

The BioBall Delta Ceramic Head may be combined with a titanium adapter, which is then attached to the prosthesis stem. The heads are to be combined exclusively with inlays or cups made of BIOLOX forte / delta1 or with inlays or cups made of PE (UHMWPE).

TGA Public Summary