K2M earns FDA clearance to boost complex spine surgery system: 5 notes

Surface Technology

K2M received FDA 510(k) clearance for its Dual Differential Correction Philosophy and Technique, which is designed to enhance the Mesa Platform Technology.

Here are five things to know:

1. The DDC Philosophy and Technique combines rod rigidity and degree of bend with Mesa Platform Technology to improve outcomes in patients with sagittal imbalance.

2. Designed with top-loading and low-profile screws as well as Zero-Torque Technology, the Mesa platform can lock in a single step without applying torsional stress to the spine.

3. Used in conjunction with Mesa, BACS Patient-Specific Rods are designed to help surgeons create pre-contoured rods, rails and templates to match the preoperative plan.

4. K2M manufactures the rods and rails using a machine rolling method, which replaces the manual three-point bending method that can sometimes reduce rod fatigue and strength.

5. By using data from K2M's BACS Surgical Planner, the rods and rails are created with multi-contoured designs and can be used with the company's Mesa, Everest and Denali Spinal Systems.

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