510(k) Report

510(k) · Cleared

Cleared

CREO® Stabilization System, REVERE® Stabilization System

K181068510(k) TraditionalCleared Jun 29, 201867-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Globus Medical, Inc. · PGM Growing Rod System

Cleared on Jun 29, 2018 as substantially equivalent to K133904 (Medtronic Sofamor Danek USA, 2014) and 10 other predicates after a 67-day review. Its family tree reaches back 19 generations to 1985. 1 of the 462 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Jun 29, 2018
Review
67 days
Class
Class II
Product code
PGM
Recalls
None
Predicates
11

Its longest line of descent runs back 19 generations to K853033 (1985). 459 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 1 of the 462 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2018: 2 other ancestors2016: 3 other ancestors2015: 5 other ancestors2014: 8 other ancestors2013: 10 other ancestors2012: 14 other ancestors2009: 18 other ancestors2006: 23 other ancestors2017: 3 other ancestors2011: 22 other ancestors2010: 16 other ancestors, 1 with a Class I recall12008: 24 other ancestors2007: 20 other ancestors2005: 37 other ancestors2004: 46 other ancestors2003: 23 other ancestors2001: 35 other ancestors2000: 23 other ancestors1999: 16 other ancestors1998: 16 other ancestors1996: 9 other ancestors1978: 3 other ancestors2002: 21 other ancestors1997: 9 other ancestors1993: 3 other ancestors1995: 13 other ancestors1994: 5 other ancestors1988: 2 other ancestors1987: 1 other ancestor1984: 2 other ancestors1992: 2 other ancestors1990: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 1 other ancestor2022: 1 descendant cleared2026: 1 descendant clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001×2: 2 generations cleared close together, K022190 (2002), K030103 (2003) K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K111571 · Viper Systems · Johnson & Johnson · 2011K121016 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 2012×2: 2 generations cleared close together, K130330 (2013), K131784 (2013) ×2: 2 generations cleared close together, K133944 (2014), K141873 (2014) K161028 · K2M Growing Spine System · K2m, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 41 other ancestors, 1 with a Class I recall13 generations back: 64 other ancestors4 generations back: 101 other ancestors5 generations back: 83 other ancestors6 generations back: 54 other ancestors7 generations back: 32 other ancestors8 generations back: 28 other ancestors9 generations back: 18 other ancestors10 generations back: 8 other ancestors11 generations back: 1 other ancestor 1 generation forward: 2 descendants K161028 · K2M Growing Spine System · K2m, Inc. · 2016K141873 · Range/Mesa/Denali Spinal System · K2m, Inc. · 2014K133944 · Range, Spinal System, Everest Spinal System · K2m, Inc. · 2014K131784 · Range Spinal System · K2m, Inc. · 2013K130330 · Range Spinal System · K2m, Inc. · 2013K121016 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 2012K111571 · Viper Systems · Johnson & Johnson · 2011K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−15−10−50
  1. Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 15 generations between
  3. 3 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  4. 2 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  5. 1 generation backK161028 K2M Growing Spine SystemK2m, Inc. · 2016
  6. This deviceK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
  7. Descendant · cites it directly · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026
  8. Descendant · cites it directly · 0 of its ownK213196 MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
Show all 19 generations
  1. Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 18 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 17 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 16 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 15 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 14 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 13 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 12 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 11 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 10 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 9 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 8 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 7 generations backK111571 Viper SystemsJohnson & Johnson · 2011
  14. 6 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  15. 5 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
  16. 4 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
  17. 3 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
  18. 2 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
  19. 1 generation backK161028 K2M Growing Spine SystemK2m, Inc. · 2016
  20. This deviceK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · cites it directly0descendants
  • K213196MARVEL™ Growing RodsGlobus Medical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−18K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−17K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−16K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−15K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−14K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−13K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−12K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−11K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−10K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−9K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−8K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−7K111571Viper SystemsJohnson & Johnson2011—
−6K121016Range Spinal System (Mesa and Denali)K2m, Inc.2012—
−5K130330Range Spinal SystemK2m, Inc.2013—
−4K131784Range Spinal SystemK2m, Inc.2013—
−3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.2014—
−2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.2014—
−1K161028K2M Growing Spine SystemK2m, Inc.2016—
0 (this device)K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.2018—
+1K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System…Globus Medical, Inc.2026—
+1K213196MARVEL™ Growing RodsGlobus Medical, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197830
198420
198510
198620
198710
198820
198910
199020
199220
199330
199450
1995130
199690
199790
1998160
1999160
2000230
2001350
2002210
2003230
2004460
2005370
2006230
2007200
2008240
2009180
2010161
2011220
2012140
2013100
201480
201550
201630
201730
201820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202610
FIG. 1 — Lineage of K181068, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PGM device

  1. #1 K251961 SDS Growing Rodscore 12.2 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K133904CD Horizon Spinal System Growth Rod Set
Summary page 6
…Growing Rod System Product Code: PGM Regulatory Class: Unclassified Primary Predicate: Medtronic CD HORIZON Growth Rod (K133904, K150200) Additional K2M Growing Spine System (K161028) Predicates: CREO® Stabilization System…
Medtronic Sofamor Danek USA2014—
*K150200CD HORIZON Growth Rod Conversion Set
Summary page 6
…owing Rod System Product Code: PGM Regulatory Class: Unclassified Primary Predicate: Medtronic CD HORIZON Growth Rod (K133904, K150200) Additional K2M Growing Spine System (K161028) Predicates: CREO® Stabilization System…
Medtronic Sofamor Danek USA, Incorporated2015—
*K161028K2M Growing Spine System
Summary page 6
…Regulatory Class: Unclassified Primary Predicate: Medtronic CD HORIZON Growth Rod (K133904, K150200) Additional K2M Growing Spine System (K161028) Predicates: CREO® Stabilization System (K124058, K153203, K172269, K180210)…
K2m, Inc.2016—
*K124058Creo Stabilization System
Summary page 6
…CD HORIZON Growth Rod (K133904, K150200) Additional K2M Growing Spine System (K161028) Predicates: CREO® Stabilization System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395,…
Globus Medical, Inc.2013—
*K153203Navigation Instruments
Summary page 6
…N Growth Rod (K133904, K150200) Additional K2M Growing Spine System (K161028) Predicates: CREO® Stabilization System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395, K133350)…
Globus Medical, Inc.2016—
*K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…
Summary page 6
…Rod (K133904, K150200) Additional K2M Growing Spine System (K161028) Predicates: CREO® Stabilization System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395, K133350) Purpose:…
Globus Medical, Inc.2018—
*K180210CREO® Stabilization System
Summary page 6
…904, K150200) Additional K2M Growing Spine System (K161028) Predicates: CREO® Stabilization System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395, K133350) Purpose: The purp…
Globus Medical, Inc.2018—
*K061202Revere Stabilization System
Summary page 6
…CREO® Stabilization System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395, K133350) Purpose: The purpose of this submission is to request clearance for additional indications for CREO®…
Globus Medical, Inc.2006—
*K091782Revere 6.35 Stabilization System
Summary page 6
…CREO® Stabilization System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395, K133350) Purpose: The purpose of this submission is to request clearance for additional indications for CREO® and REVE…
Globus Medical, Inc.2009—
*K113395Revere 4.5 Stabilization System
Summary page 6
…bilization System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395, K133350) Purpose: The purpose of this submission is to request clearance for additional indications for CREO® and REVERE® in-li…
Globus Medical, Inc.2012—
*K133350Revere Stabilization System
Summary page 6
…n System (K124058, K153203, K172269, K180210) REVERE® Stabilization System (K061202, K091782, K113395, K133350) Purpose: The purpose of this submission is to request clearance for additional indications for CREO® and REVERE® in-line connec…
Globus Medical, Inc.2014—

Also cleared against K133904: 8 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260
K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 12 months on median.
  • 52 of the 459 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K253739 (Globus Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 8 other devices also cite its predicate K133904.

How does its category compare?

All PGM devices

PGM Growing Rod System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · PGM

1in 2025

2014: 42015: 12016: 12017: 12018: 22019: 12020: 12022: 12025: 12026 (partial year): 1
2007high 4 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGM

81in 2014

2014: 81 days median
2007high 81 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PGM

No recall names PGM since 2007.

Adverse event reports per year · PGM

7in 2025

2014: 52015: 12016: 92017: 42018: 12020: 12022: 52023: 32024: 12025: 7
2007high 9 (2016) · low 0 (2007)2025

MAUDE reports naming product code PGM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
201448105
20151—01
20161—09
20171—04
20182—01
20191—00
20201—01
20210—00
20221—05
20230—03
20240—01
20251—07
20261—0—

What is it indicated for?

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…

Read the full statement (102 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K133904

8 other devices cite the same predicate.

  • K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc. · 2018
  • K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated · 2017
  • K161028K2M Growing Spine SystemK2m, Inc. · 2016
  • K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated · 2015
  • K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 20141 recall
  • K142114Xia® Growth Rod Conversion SetStryker Corporation · 2014

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

Recent decisions in PGM

The PGM category page

  • K251961SDS Growing RodBAAT Medical Products B.V. · 2026
  • K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp. · 2025
  • K213196MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
  • K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation · 2020
  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019

https://510kreport.com/device/K181068 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181068: CREO® Stabilization System, REVERE® Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181068

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026