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 immobilize and stabilize spinal segments as an adjunct to fusion in treating acute and chronic thoracic, lumbar, and sacral spine instabilities and deformities in skeletally mature patients. It can also be used in pediatric patients for posterior pedicle screw fixation to treat progressive spinal deformities and other conditions. The device is used with autograft and/or allograft.

The patient-specific K-ROD is made from Ti-6Al-4V ELI titanium alloy per ASTM F136, available in 5.5 mm and 6.0 mm diameters. It is substantially identical in shape, size, material, and manufacturing process to previously cleared predicates. The device maintains the same intended use of preserving spine shape until fusion occurs and demonstrates similar mechanical strength as the primary predicate K-ROD.

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

The subject device is identical to the K-ROD cleared in K211981, K232650, and K251804, using the same material and manufacturing process with substantially equivalent design and strength characteristics. Testing performed under ASTM F1717 and F1798 was identical in setup and parameters to prior clearances, and engineering analysis confirmed no new worst-case scenarios were created when used with Expedium and TriALTIS Spine Systems. Therefore, the device is substantially equivalent to legally marketed predicate devices.