KHEIRON® Spinal Fixation System, including patient specific K-ROD

The KHEIRON® Spinal Fixation System with patient-specific K-ROD is a thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature and pediatric patients as an adjunct to fusion. It treats acute and chronic spinal instabilities, deformities, degenerative disc disease, scoliosis, fractures, tumors, and pseudarthrosis of the thoracic, lumbar, and sacral spine.

The patient-specific K-ROD is identical to the previously cleared K-ROD (K211981, K232650, K251804), manufactured from Ti-6Al-4V ELI per ASTM F136 in 5.5 mm and 6.0 mm diameters. The Vital™ Spinal Fixation System components that interface with the K-ROD are identical to those cleared in K240539. Both devices use the same material, shape, sizes, and manufacturing process.

ASTM F1717 (dynamic compression bending), ASTM F1798 (static axial and torsional gripping capacity), and ASTM F136 (titanium alloy specification).

The K-ROD used with the Vital™ Spinal Fixation System is substantially equivalent because it is identical in design, material, and manufacturing to the predicate K-ROD, and mechanical testing demonstrated similar strength characteristics. Engineering analysis confirmed no new worst-case scenarios were created, and both subject and predicate devices share the same intended use and indications for use.