Origin™ TT Stem

The Origin™ TT Stem is a cementless hip femoral prosthesis manufactured from titanium alloy with a titanium and hydroxyapatite coating. It is intended to replace a hip joint in patients with degenerative joint disease, inflammatory arthritis, congenital hip dysplasia, traumatic injury, or failed prior hip surgery where bone stock is sufficient to support the implant.

The Origin TT Stem has nearly identical technological characteristics to its predicates: same indications for use, same materials of manufacture (titanium alloy ISO 5832-3 with plasma spray coatings), same structure support mechanism (cementless fixation with proximal coating), same principle of operation, compatible sizes, and the same basic design with a 12/14 taper compatible with existing femoral heads and acetabular cup systems.

ISO 21535 (hip joint replacement implants requirements), ASTM F2996 (finite element analysis of metallic hip femoral stems), ISO 7206-4 (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 Origin TT Stem is substantially equivalent because it shares the same intended use and indications for use as the predicate devices (Spartan, Encore, Origin, and DePuy Actis DuoFix stems), operates on the same principle, incorporates the same basic design, and uses the same materials. Non-clinical performance testing on worst-case sizes demonstrates that strength is sufficient for intended use and comparable to predicates, and any minor differences do not raise new safety or effectiveness concerns.