# K162884: SpineGuard DSG Zavation Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spineguard S.A.
- Decided: Jan 12, 2017 after 90 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921979 (1993). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152747: DSG Threaded Drill System, Spineguard S.A. (2016) Summary page 4.

## Most influential descendants
- K201454: DSG Connect Technology (2021), 1 descendant of its own
- K222106: Waypoint GPS (2023), 0 descendants of its own

## Indications for use
The DSG™ Zavation Screw System is indicated for use with Zavation pedicle screws during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The DSG™ Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

Source page: https://510kreport.com/device/K162884
Methodology: https://510kreport.com/methodology