Vital™ Spinal Fixation System

The Vital™ Spinal Fixation System is a thoracolumbar and sacroiliac fixation system consisting of spinal rods, pedicle screws, hooks, and connectors made from medical-grade titanium alloy or cobalt chromium. It is designed to provide temporary stabilization during spinal fusion surgery for conditions including degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, pseudoarthrosis, and failed fusion. The system is indicated for both skeletally mature and adolescent patients and is intended to be removed after solid fusion is achieved.

The subject Vital System has the same technological characteristics as the predicate Vital System (K240539) with no new components added. The submission establishes compatibility with the KHEIRON® Spinal Fixation System patient-specific K-ROD, which is substantially equivalent in materials, dimensions, and performance when used in place of a Vital System rod. Updates include MR Conditional parameter revisions and automated cleaning instructions compliant with ANSI/AAMI ISO 17664-1:2022.

ASTM F1717 (dynamic compression bending), ASTM F1798 (axial and torsional grip), ASTM F2182-19e2 (RF Induced Heating evaluation in bone-inclusive phantom), and ANSI/AAMI ISO 17664-1:2022 (automated cleaning instructions).

The subject Vital System is substantially equivalent to the predicate because there are no design changes or new components; intended use, indications, design, manufacturing methods, and operational principles remain the same or similar. Performance testing of the Vital System–K-ROD construct met all acceptance criteria under applicable ASTM standards, and RF heating and cleaning evaluation demonstrated the system remains safe under updated MR conditional parameters. The compatibility with KHEIRON® K-ROD does not introduce new technological characteristics or risks.