Device Dossier

Origin Stem - Coated femoral stem prosthesis, modular

Device Dossier for Origin Stem - Coated femoral stem prosthesis, modular (Coated femoral stem prosthesis, modular, Class III, sponsor Signature…

Intended purpose

The Origin Stem is part of Signature Orthopaedics' hip replacement range intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are intended for: - Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid arthritis - Correction of functional deformity including congenital hip dysplasia - Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - Dislocation Risks (when used with SignaSure range)

Functional description

The Origin Stem consists of HA coating to promote bone ongrowht when implanted in the patient's femoral canal. The device includes a 12/14 Euro taper at the end of its neck which mates to a modular femoral head as part of a hip joint replacement. The device is manufactured from Ti6Al4V alloy. For cementless use.

TGA Public Summary