# K222355: PathKeeper System

- Pathway: 510(k) (Traditional)
- Applicant: Pathkeeper Surgical, Ltd.
- Decided: Mar 8, 2023 after 216 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050438 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162375: Envision 3D: Image Guidance System, 7D Surgical, Inc. (2016) Summary page 4.

## Indications for use
The PathKeeper System is a stereotaxic image guidance system intended for the spatial positioning and orientation of surgical instruments used by orthopedic surgeons and neurosurgeons during posterior approach spinal fusion surgeries when pre-operative CT imagery is available. The System, with PathKeeper spine surgery planning and navigation software and 3D optical camera, is intended as an aid for precisely locating anatomical structures in posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region. The device is indicated for posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K222355
Methodology: https://510kreport.com/methodology