# K181068: CREO® Stabilization System, REVERE® Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 29, 2018 after 67 days
- Product code: PGM (Growing Rod 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
Longest line of descent: 19 generations back to K853033 (1985). 459 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 462 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133904: CD Horizon Spinal System Growth Rod Set, Medtronic Sofamor Danek USA (2014) Summary page 6.
- K150200: CD HORIZON Growth Rod Conversion Set, Medtronic Sofamor Danek USA, Incorporated (2015) Summary page 6.
- K161028: K2M Growing Spine System, K2m, Inc. (2016) Summary page 6.
- K124058: Creo Stabilization System, Globus Medical, Inc. (2013) Summary page 6.
- K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 6.
- K172269: FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System, Globus Medical, Inc. (2018) Summary page 6.
- K180210: CREO® Stabilization System, Globus Medical, Inc. (2018) Summary page 6.
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 6.
- K091782: Revere 6.35 Stabilization System, Globus Medical, Inc. (2009) Summary page 6.
- K113395: Revere 4.5 Stabilization System, Globus Medical, Inc. (2012) Summary page 6.
- K133350: Revere Stabilization System, Globus Medical, Inc. (2014) Summary page 6.

## Most influential descendants
- K253739: SCRIPT™ Rods, CREO™ Stabilization System,  REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 descendants of its own
- K213196: MARVEL™ Growing Rods (2022), 0 descendants of its own

## Indications for use
In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct. In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Source page: https://510kreport.com/device/K181068
Methodology: https://510kreport.com/methodology