Fitbone® Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

The Fitbone Trochanteric, FITBONE® TAA, and FITBONE® Transport and Lengthening System are intramedullary lengthening and fixation devices used for limb lengthening, fracture fixation, and bone transport. They are indicated for adult and pediatric patients (ages 12–21 for some indications, adult only for Transport) and are implanted by healthcare professionals familiar with orthopedic surgical procedures.

The subject implantable bone screws are made from stainless steel (ASTM F138, UNS S31673) and are available in 4.5mm and 4.0mm diameters with lengths ranging from 20–110mm, featuring single or double threads. They are sterilized by gamma radiation to achieve a 10⁻⁶ sterility assurance level and are compatible with the Fitbone nailing systems. The design differs minimally from predicates, with length variations but identical thread design and material composition.

USP 40–NF35:2017 Bacterial Endotoxins Test (LAL); USP 40–NF35:2017 Medical Devices Bacterial Endotoxins and Pyrogen Tests; ANSI/AAMI ST72:2016 Bacterial endotoxins test methodologies; FDA 2012 Guidance for Industry Pyrogen and Endotoxins Testing; ASTM F138 for stainless steel surgical implants.

The subject device is substantially equivalent because it is a line extension of previously cleared predicate screws (Fitbone Trochanteric K233867, FITBONE® TAA K203399, Fitbone Transport and Lengthening System K232169) with identical material, sterilization, and thread design. Length variations do not introduce new safety or performance issues because similar lengths exist in cleared predicates, and bench testing confirmed no adverse impact from design modifications.