Longboard Revision Hip Stem

The Longboard Revision Hip Stem is a femoral (thighbone) implant component for revision hip replacement surgery in patients with insufficient revision options. It is a titanium alloy stem with a tapered, finned body and a distal locking screw, designed for cementless fixation and compatible with previously cleared Signature Orthopaedics femoral head components. The device is indicated for patients undergoing hip revision due to failed previous hip surgery, osteoarthritis, rheumatoid arthritis, traumatic injury, or other conditions requiring hip joint replacement.

The Longboard Revision Stem and its predicate devices share nearly identical technological characteristics: same indications for use, titanium alloy materials of manufacture (ISO 5832-3, ASTM F136), identical structure support mechanism and operating principle, comparable sizes, and fundamentally the same design approach with a symmetrical 135° neck angle and 12/14 taper for femoral head compatibility. Minor design differences (such as the finless distal tip for version adjustments) do not introduce new safety or effectiveness concerns.

Non-clinical testing was conducted per ISO 21535 (hip joint replacement implants), ASTM F2996 (finite element analysis of hip femoral stems), ISO 7206-4 (endurance properties of stemmed femoral components), ISO 7206-6 (endurance properties of the neck region), and ASTM F543 (metallic medical bone screws). Testing evaluated range of motion, stem and neck fatigue via finite element analysis and bench testing on worst-case device sizes.

The Longboard Revision Stem is substantially equivalent because it has identical intended use and indications for use as the predicate devices (Smith & Nephew REDAPT and others), employs the same operating principle and basic tapered stem design, uses the same titanium alloy materials, and demonstrated sufficient structural strength through non-clinical fatigue and mechanical testing comparable to the predicates. The minor design differences (finless distal tip, specific geometry) do not raise new safety or effectiveness questions, and performance testing confirms the device is at least as safe and effective as the legally marketed predicate devices.