# K222106: Waypoint GPS

- Pathway: 510(k) (Traditional)
- Applicant: Waypoint Orthopedics, Inc.
- Decided: May 12, 2023 after 298 days
- Product code: QWP (Optical Neurosurgical Nerve Locator)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921979 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201454: DSG Connect Technology, Spineguard S.A. (2021) Summary page 4.

## Indications for use
The Waypoint GPS™ is indicated for use during pedicle screw pilot hole drilling to provide visual feedback to the surgeon of changes in color to the tissue at the tip of the probe that may indicate contact with soft tissues and possible vertebral cortex perforation. The Waypoint GPS™ is indicated for use in both open and percutaneous (MIS) procedures.

Source page: https://510kreport.com/device/K222106
Methodology: https://510kreport.com/methodology