K2M received FDA 510(k) clearance for surgical guidance that enhances its Mesa Platform Technology using patient-specific rods and rails.
Here are four things to know:
1. The FDA clearance involves K2M's Dual Differential Correction Philosophy and Technique. The DDC philosophy combines rod rigidity and degree of bend with the Mesa Platform Technology for use in patients with sagittal imbalance.
2. Additionally, Mesa can be used with the Bacs Patient-Specific Rods to help create pre-contoured rods, rails and templates that match the surgeon's preoperative plan.
3. Bacs Patient-Specific Rods and Rails can be used with K2M's Mesa, Everest and Denali Spinal Systems.
4. Bacs is designed to achieve spinal balance by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal and sagittal planes.