K2M received FDA 510(k) clearance for the BACS Patient-Specific Module.
Here are five things to know:
1. Surgeons can use the BACS Surgical Planner to create pre-contoured rods, rails, and templates that match the preoperative plan.
2. The BACS Surgical Planner is part of K2M's Balance ACS platform, which provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach in the axial, coronal and sagittal planes, emphasizing Total Body Balance as a key component of surgical success.
3. This is K2M's first clearance for patient-specific devices and fifth module within the BACS platform, which is focused on achieving spinal balance by addressing each anatomical vertebral segment with a 360-degree approach in the axial, coronal, and sagittal planes.
4. K2M uses a machine rolling method to manufacture BACS Patient-Specific Rods and Rails instead of the three-point bending method that frequently reduces rod fatigue strength.
5. BACS Patient-Specific Rods and Rails can be used with the Mesa, Everest and Denali Spinal Systems.
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