FDA clears CoreLink’s CentraFix midline fixation system

[Image from CoreLink]CoreLink announced today that it won FDA 510(k) clearance for and commercially launched its CentraFix midline fixation system.

St. Louis-based CoreLink designed CentraFix as a posterior thoracolumbar pedicle screw for less invasive spinal fixation, often used with a medial-to-lateral approach known as cortical bone trajectory (CBT).

According to a news release, that technique allows for maximum contact of the pedicle screw with cortical bone with the aim of reducing incision size, limiting muscular and vascular injury and improving initial fixation.

CentraFix also features modular cobalt chrome tulip heads and titanium alloy screw shanks in various lengths and diameters for allowing screw placement in denser cortical bone, CoreLink said. he tulip heads minimize tissue disruption and simplify distraction without compromising strength.

“The CentraFix System provides unmatched intraoperative visualization and surgical flexib…

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CoreLink launches pedicle screw system

CoreLink announced today that it launched its Tiger MIS x-tab pedicle screw system designed for the correction of the thoracolumbar spine.

St. Louis-based CoreLink’s percutaneous system further expands its Tiger platform with numerous screw and rod options for treating patients with a variety of spinal pathologies with minimal tissue disruption, according to a news release.

Tiger MIS x-tab integrates with CoreLink’s standard, tower-based Tiger MIS system with polyaxial, extended tab pedicle screws to offer cross-compatibility for mini-open and percutaneous approaches.

The system’s low-profile, extended tabs stand at 130 mm long to facilitate implantation in larger patients, while a breakaway top allows for the extensions to cross when implanting in the lower lumbar spine.

“This addition to our proven tower-based Tiger MIS system allows for true percutaneous screw placement and more efficient surgeries,” CoreLink CEO Jay Bartling …

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CoreLink wins FDA clearance for standalone cervical spine system

CoreLink announced today that it received FDA 510(k) clearance for its F3D-C2 standalone cervical system for ACDF procedures.

The F3D-C2 standalone cervical device eliminates the need for a supplemental fixation plate to make ACDF (anterior cervical discectomy and fusion) procedures easier to complete and a faster process overall.

St. Louis-based CoreLink’s system includes its 3D-printed Mimetic Metal technology, incorporated into the spacer to emulate key characteristics of natural bone and provide lower stiffness than machined titaium while minimizing imaging artifact.

The company said in a news release that the F3D-C2 system will be available in multiple footprints, heights and lordotic angles.

“The F3D-C2 standalone cervical system features the only 3D-printed spine technology with both a trabecular structure and directional support lattices designed to allow for fusion throughout the entire implant,” CoreLink CEO Jay Bartling said in th…

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