US FDA clears SpineGuard’s DSG third-party pedicle screw integration module

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SpineGuard’s DSG Integration module

SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new DSG (Dynamic Surgical Guidance) integration module to be used in combination with Zavation’s spinal fusion system to make its pedicle screws “smart.”

The DSG sensor differentiates various tissue types (cancellous bone, cortical bone, blood and soft tissues) based on the analysis of the local electrical conductivity. Real-time feedback informs the surgeon of changes in tissue type by an audio signal varying in pitch and cadence. This in turn alerts the surgeon of potential breaches during pedicle screw placement and allows for screw redirection.

A DSG-enabled screw combines a bipolar sensor and a pedicle screw. The technology offers surgeons real-time audible guidance. It is also intended to enable surgeons to insert the screw directly into a vertebra without drilling a pilot hole. In minimally invasive surgery, it is designed to obviate the need for a Kirschner-wire.

Another DSG-enabled SmartScrew co-developed with Neuro France Implants (La ville-aux-Clercs, France) is currently in alpha launch in Europe with seven surgeons having started to use the system.