# K182375: CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Apr 8, 2019 after 220 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K191835: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments (2019), 2 descendants of its own
- K203153: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS (2021), 1 descendant of its own
- K253739: SCRIPT™ Rods, CREO™ Stabilization System,  REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K182375
Methodology: https://510kreport.com/methodology