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

The KHEIRON® Spinal Fixation System, including patient specific K-ROD, is intended to provide immobilization and stabilization of spinal segments in skeletally mature and pediatric patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. These conditions include degenerative disc disease, degenerative spondylolisthesis, fracture, dislocation, deformities, spinal stenosis, spinal tumor, pseudarthrosis, and failed previous fusion. The system is used with autograft and/or allograft.

The patient specific K-ROD is made from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm. The K-ROD is substantially equivalent in shape, sizes, material, and manufacturing process to the predicate devices. The device is compatible with multiple pedicle screw systems including the Orthofix Virata System (with screws ≥4.0mm and ≥20mm in length). The K-ROD maintains similar strength characteristics as the primary predicate per verification and validation activities.

ASTM F136 (titanium alloy material specification), ASTM F1717 (dynamic compression bending), ASTM F1798 (static axial and torsional gripping capacity), and ISO 13485 (quality management system requirements including design controls, nonconforming product, corrective action, and preventative action).

The subject K-ROD is identical to the K-ROD cleared in prior 510(k)s (K211981, K232650, K251804, K253721, K253990) and the Orthofix Virata System components are identical to those cleared in K250908. Engineering analysis and mechanical testing demonstrated that the K-ROD used with the Orthofix Virata System has identical test parameters, creates no new worst-case scenarios, and maintains substantial equivalence in intended use, indications, material, design, and strength to the predicate devices.