# K202184: Practical Navigation Surgical Guidance System (PNSGS)

- Pathway: 510(k) (Traditional)
- Applicant: Practical Navigation, LLC
- Decided: Feb 24, 2021 after 204 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: 19 generations back to K040583 (2004). 427 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 433 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K223070: Remi Robotic Navigation System (2022), 4 descendants of its own
- K232413: Fusion Robotic Navigation System (2023), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own
- K223350: Remi Robotic Navigation System (2023), 0 descendants of its own

## Indications for use
The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.

Source page: https://510kreport.com/device/K202184
Methodology: https://510kreport.com/methodology