Origin™ Cemented Hip Stem

The Origin™ Cemented Hip Stem is a femoral hip prosthesis manufactured from nitrogen stainless steel for use in total hip arthroplasty with cement fixation. It is indicated to replace a hip joint in patients with sufficient bone stock who have conditions such as osteoarthritis, rheumatoid arthritis, hip dysplasia, traumatic injury, or failed prior hip surgery.

The subject device and predicate devices share nearly identical technological characteristics: same indications for use, same materials of manufacture (nitrogen stainless steel), same structure support mechanism, same principle of operation, same sizes, and same basic design. The device features a 12/14 taper for compatibility with Signature's range of previously cleared femoral head components and acetabular cups.

ISO 21535 (Joint replacement implants — specific requirements for hip joint replacement implants), ASTM F2996 (Finite Element Analysis of Non-Modular Metallic Orthopaedic Hip Femoral Stems), ISO 7206-4 (Determination of endurance properties and performance of stemmed femoral components), and ISO 7206-6 (Endurance properties testing and performance requirements of neck region of stemmed femoral components).

The subject device has the same intended use, indications for use, operating principle, basic design, and materials as the predicate devices. Non-clinical testing including range of motion, stem and neck fatigue FEA, and fatigue testing on worst-case sizes demonstrated that the device's strength is sufficient for intended use. Since the minor differences do not raise new questions of safety and effectiveness, the device is substantially equivalent to legally marketed predicates.