K2M Receives FDA Clearance for BACS Patient-Specific Module

By Julie A. Vetalice

K2M received FDA 510(k) clearance to market BACS® Patient-Specific devices. This fifth module in the BACS platform allows for the creation of pre-contoured rods, rails and templates, and is the company's first patient-specific indication.

A machine rolling manufacturing method avoids rod fatigue that may be incurred from the manual, 3-point bending method. When used with data from the BACS Surgical Planner, rods and rails can be shaped into complex multi-contoured designs. BACS Patient-Specific Rods and Rails can be used with the MESA®, EVEREST® and DENALI® systems.

K2M’s Balance ACS® (BACS) platform, launched in 1Q17, addresses each anatomical vertebral segment with a 360-degree approach in the axial, coronal and sagittal planes.

Source: K2M

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory