
Spinal Fixation System
The purpose of this 5 10O(k) submission is to add an adjustable-length spinous process fusion plate to the Lanx Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system. The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F 1580, ASTM F 136 and ASTM Fl 537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.