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

Written by Jackie Drees | October 11, 2018 | Print  |

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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U of Nebraska-Lincoln researchers developing 3D-printed dissolving implants: 5 insights

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