510(k) · Cleared
ClearedMARVEL™ Growing Rods
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · PGM Growing Rod System
Cleared on Dec 19, 2022 as substantially equivalent to K181068 (Globus Medical, Inc., 2018) after a 446-day review. Its family tree reaches back 20 generations to 1985. 1 of the 461 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 19, 2022
- Review
- 446 days
- Class
- Class II
- Product code
- PGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K853033 (1985). 460 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 461 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations between
- 3 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 2 generations backK161028 K2M Growing Spine SystemK2m, Inc. · 2016
- 1 generation backK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
- This deviceK213196 MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
Show all 20 generations
- Root · 20 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 19 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 18 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 17 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 16 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 15 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 14 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 13 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 12 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 11 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 10 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 9 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 8 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 7 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 6 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 5 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 4 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 3 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 2 generations backK161028 K2M Growing Spine SystemK2m, Inc. · 2016
- 1 generation backK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
- This deviceK213196 MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −19 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −18 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −17 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −16 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −15 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −14 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −13 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −12 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −11 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −10 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −9 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −8 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −7 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −6 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −5 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −4 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −3 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −2 | K161028 | K2M Growing Spine System | K2m, Inc. | 2016 | — |
| −1 | K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018 | — |
| 0 (this device) | K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 3 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 13 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 16 | 0 |
| 1999 | 16 | 0 |
| 2000 | 23 | 0 |
| 2001 | 35 | 0 |
| 2002 | 21 | 0 |
| 2003 | 23 | 0 |
| 2004 | 46 | 0 |
| 2005 | 37 | 0 |
| 2006 | 23 | 0 |
| 2007 | 20 | 0 |
| 2008 | 24 | 0 |
| 2009 | 18 | 0 |
| 2010 | 16 | 1 |
| 2011 | 22 | 0 |
| 2012 | 14 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
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 K251961 SDS Growing Rodscore 12.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181068 | CREO® Stabilization System, REVERE® Stabilization SystemSummary page 4…cle Screw System Product Code: PGM Regulatory Class: Class II, Panel Code: 87 Primary Predicate: In-Line Connector Growing Rods (K181068) Reference Device: SUSTAIN® R Spacers, PATRIOT® Spacers (K152022) Purpose: The purpose of this submission is to request clearan… | 2018 |
| † | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 52 of the 460 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K181068.
How does its category compare?
All PGM devicesPGM Growing Rod System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PGM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGM
81in 2014
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
MAUDE reports naming product code PGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 81 | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MARVEL" 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 as stated in the FDA summary.
https://510kreport.com/device/K213196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213196: MARVEL™ Growing Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213196
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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