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

Signature Orthopaedics' hip replacement range are 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 indicated 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 Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement - Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Functional description

The Origin Stem has an HA coating to promote bone ongrowth 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