CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug Administration (FDA) for its CentraFix midline fixation system—which features modular cobalt chrome tulip heads that CoreLink say are designed to allow for intraoperative flexibility and increase visualisation in smaller incisions.
CentraFix is a posterior thoracolumbar pedicle screw system designed for less invasive spinal fixation often used with a medial-to-lateral approach, known as cortical bone trajectory (CBT).
This technique maximixes contact of the pedicle screw with cortical bone and is intended to reduce incision size, limit muscular and vascular injury, and improve initial fixation, say CoreLink.
The CentraFix system features modular cobalt chrome tulip heads and titanium alloy screw shanks in various lengths and diameters, designed specifically to allow screw placement in denser cortical bone.
Jay Bartling, CEO of CoreLink, said: “The CentraFix system provides unmatched intraoperative visualisation and surgical flexibility for the midline approach. Our in-house development and manufacturing have allowed us to produce our most innovative fixation system to date.”