TriALTIS™ Spine System

The TriALTIS™ Spine System is a posterior spinal fixation system that provides immobilization and stabilization of the thoracic, lumbar, and sacral spine (T1-S2) as an adjunct to fusion. It consists of bone anchors (screws) connected by longitudinal rods and connectors for treating acute/chronic spinal instabilities, deformities, trauma, degenerative disc disease, and tumors in both skeletally mature and pediatric patients. Fenestrated screws can also be augmented with spinal cement for limited stabilization in advanced tumor cases.

The TriALTIS™ System components conform to ASTM F136 and Nitinol to ASTM F2063 standards. The technological evaluation demonstrates that the subject device's intended use, technological characteristics, and performance data are substantially equivalent to predicate devices, with evaluation including component-level testing of interconnection mechanisms using ASTM F1798 for static and fatigue properties.

ASTM F1798 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants,' specifically addressing axial and torsional grip testing and flexion-extension testing. ASTM F136 and ASTM F2063 for material conformance.

The device demonstrates substantial equivalence because its indications for use are identical to the predicate device K242042 (cleared TriALTIS™ Spine System), and non-clinical testing shows that the TriALTIS™ Spine System components perform equivalently to predicate systems (EXPEDIUM connectors) when evaluated on static and fatigue properties of interconnection mechanisms. The technological characteristics and performance data support that this subject device poses no greater risks and provides equivalent clinical benefit compared to the legally marketed predicates.