XT3 System

The XT3 System is an external bone fixation device composed of a fixator, half pins, and instrumentation (spacer, drill, and cut guide). It is indicated for fracture fixation and bone transport of the tibia in adults. The fixator and instruments are single-use, non-sterile devices supplied for steam sterilization prior to use.

The XT3 System design is similar to the Orthofix Modulysystem's LRS (Limb Reconstruction System) components, using an external fixator and half pins for fracture stabilization and bone transport via locked skeletal fixation and distraction osteogenesis. Both systems employ the same surgical technique and mechanism of operation.

ASTM F1541-17 Annex 7 was used for axial load testing, four-point bend testing, and torsion testing to evaluate stiffness, strength, and dynamic loading performance of the external skeletal fixator-bone constructs.

The XT3 System is substantially equivalent because it utilizes the same technological principles and design features as the Orthofix Modulysystem predicate device. Comprehensive mechanical testing per ASTM F1541-17 demonstrated that the XT3 System performs substantially equivalently to the predicate in axial compression, four-point bending, and torsion. Cadaver testing confirmed successful use per intended indications. Although indications statements differ slightly, both devices are external fixators intended for tibial fracture fixation and bone transport in adults, with no new safety or effectiveness questions raised.