CurvaFix Low Profile System

The CurvaFix Low Profile System is a collection of flexible intramedullary implants designed to fix pelvic fractures. The implants have a threaded, self-tapping distal end and a proximal driving torque interface. An integral shape lock feature allows the implant to transition from flexible to rigid after placement, and can be reversed if explantation is needed. The system comes in two diameters (7.5mm and 9.5mm) and lengths from 90mm to 210mm, with washers available for load distribution in poor bone quality.

The CurvaFix Low Profile System has the same basic design, minor diameter, and major diameter as the primary predicate device (CurvaFix IM System). Differences include length range, proximal head/housing design, washer specifications, and instrument updates. The implants maintain identical material, mechanism of action, and stabilization method as the predicate devices.

Mechanical testing was performed according to ASTM F543-23 and ASTM F1264-16e1:2024. Testing included driving torque, pullout load, torsional properties, static four-point bend, bending fatigue, integrity after shipping, implant radius of curvature, implant torque to lock and unlock, implant cable tensile, and washer pull-through.

The device has identical indications for use (pelvic fracture fixation) as the primary predicate, differing only in product name branding. The CurvaFix Low Profile System maintains the same anatomic location, material, mechanism of action, and method of stabilization as the predicate devices. All design differences (length range, proximal housing, washers, instruments) were determined not to raise different questions of safety and effectiveness. Worst-case mechanical testing met all acceptance criteria established for the primary predicate device, demonstrating equivalent performance.