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

The KHEIRON® Spinal Fixation System, including patient-specific K-ROD, is a spinal stabilization device intended to provide immobilization of thoracic, lumbar, and sacral spine segments in skeletally mature and pediatric patients as an adjunct to fusion surgery. It treats conditions including degenerative disc disease, spondylolisthesis, fractures, deformities, stenosis, tumors, pseudarthrosis, and failed previous fusions.

The patient-specific K-ROD is manufactured from Ti-6Al-4V ELI per ASTM F136 in diameters of 5.5 and 6.0 mm. It is identical in design, material, shape, size, and manufacturing process to the predicate K-ROD devices. The device is compatible with Seaspine Mariner System components designed for 5.5 mm and 6.0 mm rods with screws 4.5 mm or larger and at least 25 mm in length.

ASTM F1717 (dynamic compression bending and static torsion testing), ASTM F1798 (static axial and torsional gripping capacity testing).

The K-ROD subject device is physically and materially identical to predicates K211981 and K232650. Testing of K-ROD mechanical characteristics when used with the Seaspine Mariner System—using identical test setup and parameters as the original predicates—demonstrated equivalent strength and performance. Engineering analysis comparing K-ROD with Seaspine Mariner's titanium alloy rods determined no new worst-case scenario was created, establishing compatibility without introducing new safety or performance concerns.