Trivicta® Hip Stem

The Trivicta Hip Stem is a single-piece, tapered, uncemented hip prosthesis made of titanium alloy with hydroxyapatite and sintered bead coatings for press-fit fixation in the femur. It is intended for total and hemi-hip arthroplasty in patients with osteoarthritis, rheumatoid arthritis, avascular necrosis, proximal femoral fractures, failed prior hip surgery, and certain bone tumors or structural abnormalities where sufficient bone stock exists.

Trivicta is identical to the previously cleared Trivicta predicate (K233758) in materials, fixation mechanism, taper/trunnion design (12/14), neck angle (132°), collar/collarless options, packaging, and sterilization method. The subject device extends the size range with lengths of 97–101 mm, horizontal offsets of 36–43 mm, vertical offsets of 27–29 mm, and resection angle of 41°, offering both standard and extended offset variants.

ISO 11137 (sterilization validation to 10⁻⁶ sterility assurance level), ISO 11607 (shelf-life packaging validation), ISO 10993-1 (biocompatibility), ISO 21535:2023 (range of motion test), ISO 7206-6:2013 (neck fatigue test), ISO 7206-4:2010 (distal stem fatigue test), and ASTM F2582-20 (impingement performance analysis).

Trivicta shares identical indications for use, materials, manufacturing design, fixation principles, and biocompatible coatings with its primary predicate (K233758). The subject device simply extends the size range of the already-cleared predicate with dimensions comparable to the reference predicate (DepuySynthes Actis DuoFix). Mechanical testing demonstrates equivalent performance characteristics, and biocompatibility was established by recognized standards. No clinical testing was required because the technological and design similarities to legally marketed predicates obviate that burden.