# K220862: E-GPS Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Jul 14, 2022 after 112 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: 20 generations back to K003155 (2001). 642 ancestors in all.
7 later devices descend from it; 4 cite it directly.
1 of 650 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 5.
- K200303: Reform Pedicle Screw System, Precision Spine (2020) Summary page 5.
- K173130: Reform® Midline Cortical Screw System, Precision Spine, Inc. (2017) Summary page 5.

## Most influential descendants
- K232044: Invictus Robotic Navigation Instruments (2023), 3 descendants of its own
- K240951: Invictus Robotic Navigation Instruments (2024), 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
- K251780: iGPS Navigation Instruments (2025), 0 descendants of its own

## Indications for use
The E-GPS Navigated Instruments are indicated for use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The E-GPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for use as an aid for precisely locating anatomical structures and for the special positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti, Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).

Source page: https://510kreport.com/device/K220862
Methodology: https://510kreport.com/methodology