Device Dossier
BioBall® Adaptor - Femoral head/stem prosthesis adaptor
Device Dossier for BioBall® Adaptor - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor Enovis Surgical).…
- GMDN category: Femoral head/stem prosthesis adaptor
Intended purpose
The BioBall™ Adapter is part of the System which is 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
BioBall adapter titanium and can be combined with a fitting head and stem. The main indication is Revision with a well fitted prosthesis stem. The system may be used for primary interventions in order to make intra operative corrections to vary the offset, neck length, or lateralisation and ante torsion to improve the patient-specific optimal physiological joint reconstruction, the BioBall Offset Adapter may also be used. The 14/16 taper adaptor is only for use with a metal head