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# FDA Clears SpineGuard Pedicle Screw Placement System
- URL: https://www.fdaweb.com/fda-clears-spineguard-pedicle-screw-placement-system/
- Published: 2016-06-16T12:00:00.000Z
- Updated: 2026-09-14T21:10:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135959

FDA has cleared a SpineGuard 510(k) for the PediGuard Threaded DSG device for use in pedicle screw insertion. “A single-use DSG pin embedded with the bipolar sensor is inserted into the cannula of the threaded shaft and connected to the electronic processor inside the single-use DSG handle.” the company says. “The distal tip of the threaded shaft includes an awl-like tip to facilitate redirection of the device until the tip is past the pedicle isthmus.”

The company says PediGuard is the first stand-alone, handheld instrument capable of accurately detecting changes in tissue type, alerting surgeons of potential pedicular or vertebral breaches during pedicle screw site preparation. Real-time feedback, provided via audio and visual signals, gives surgeons additional information about the trajectory during pedicle preparation.