CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)

The CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) is a posterior spinal fixation system consisting of rods, screws, hooks, plates, and connecting components made from stainless steel, titanium, cobalt-chromium, or PEEK materials. It is intended for posterior, non-cervical fixation as an adjunct to fusion to treat degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumors, pseudarthrosis, and failed previous fusion in both adult and pediatric patients. The LigaMAS Head Assembly specifically provides temporary stabilization as a bone anchor during fusion development and bone fracture repair.

The subject device has the same intended use, indications for use, materials, similar overall design, fundamental technology, and sterilization as the predicate devices (K221244 and K172021). Both the subject and predicate implants share the same function and fundamental scientific technology for spinal fixation.

ASTM F1717 (Static Compression, Static Torsion, Compression Fatigue), ASTM F1798 (Axial Grip, Axial Torsion, Flexion Extension Static, Flexion Extension Fatigue), and ASTM F2503 (MRI Compatibility Evaluation).

Medtronic demonstrated substantial equivalence by showing the subject device meets the same intended use, design, materials, and fundamental technology as the predicates CD Horizon™ Spinal System (K221244) and LigaPASS™ Spinal System (K172021). All completed testing met pre-determined acceptance criteria, and for tests that were rationalized rather than performed, existing predicate data remains applicable, confirming the subject device is substantially equivalent.