510(k) · Cleared
ClearedK2M Growing Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · PGM Growing Rod System
Cleared on Jul 22, 2016 as substantially equivalent to K133904 (Medtronic Sofamor Danek USA, 2014) and 10 other predicates after a 101-day review. Its family tree reaches back 18 generations to 1985. 3 later devices descend from it.
- Decided
- Jul 22, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- PGM
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 18 generations to K853033 (1985). 321 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations between
- 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 1 generation backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- This deviceK161028 K2M Growing Spine SystemK2m, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK213196 MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
Show all 18 generations
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 16 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 15 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 14 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 13 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 12 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 11 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 10 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 9 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 7 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 6 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 5 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 4 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 1 generation backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- This deviceK161028 K2M Growing Spine SystemK2m, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018 · cites it directly2descendants
- K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · 2 generations on0descendants
- K213196MARVEL™ Growing RodsGlobus Medical, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −17 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −16 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −15 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −14 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −13 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −12 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −11 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −10 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −9 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −7 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −6 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −5 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −4 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −3 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −1 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| 0 (this device) | K161028 | K2M Growing Spine System | K2m, Inc. | 2016 | — |
| +1 | K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018 | — |
| +2 | K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System… | Globus Medical, Inc. | 2026 | — |
| +2 | 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 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 28 | 0 |
| 2002 | 18 | 0 |
| 2003 | 20 | 0 |
| 2004 | 40 | 0 |
| 2005 | 30 | 0 |
| 2006 | 18 | 0 |
| 2007 | 14 | 0 |
| 2008 | 17 | 0 |
| 2009 | 12 | 0 |
| 2010 | 9 | 0 |
| 2011 | 14 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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.
Planning a device in PGM? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133904 | CD Horizon Spinal System Growth Rod SetSummary page 5…M) Classification Name(s): Growing Rod System (Unclassified, Product Code PGM) Predicate Device(s) Primary Predicates: Medtronic CD HORIZON® Growth Rod Conversion Set (K133904) Additional Predicates: Medtronic SHILLA Growth Guidance System (K140750) K2M Range/Denali/Mesa Spinal System (K070229, K12009… | 2014 |
| * | K140750 | Shilla Growth Guidance SystemSummary page 5…PGM) Predicate Device(s) Primary Predicates: Medtronic CD HORIZON® Growth Rod Conversion Set (K133904) Additional Predicates: Medtronic SHILLA Growth Guidance System (K140750) K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141… | 2014 |
| * | K070229 | Range Spinal SystemSummary page 5…edtronic CD HORIZON® Growth Rod Conversion Set (K133904) Additional Predicates: Medtronic SHILLA Growth Guidance System (K140750) K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K… | 2007 |
| * | K120099 | Range Spinal System (Mesa and Denali)Summary page 5…CD HORIZON® Growth Rod Conversion Set (K133904) Additional Predicates: Medtronic SHILLA Growth Guidance System (K140750) K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114)… | 2012 |
| * | K121630 | Range Spinal SystemSummary page 5…N® Growth Rod Conversion Set (K133904) Additional Predicates: Medtronic SHILLA Growth Guidance System (K140750) K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114) Orthopedi… | 2012 |
| * | K141873 | Range/Mesa/Denali Spinal SystemSummary page 5…Rod Conversion Set (K133904) Additional Predicates: Medtronic SHILLA Growth Guidance System (K140750) K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114) Orthopedic Equipme… | 2014 |
| * | K141509 | Isola and Expedium Growing Spine SystemsSummary page 5…ronic SHILLA Growth Guidance System (K140750) K2M Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114) Orthopedic Equipment Company (K781443, K781448, K781449) Device Description… | 2014 |
| * | K142114 | Xia® Growth Rod Conversion SetSummary page 5…Range/Denali/Mesa Spinal System (K070229, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114) Orthopedic Equipment Company (K781443, K781448, K781449) Device Description The K2M Growing Spine System consists of screw and… | 2014 |
| * | K781443 | Harrington Spine InstrumentationSummary page 5…9, K120099, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114) Orthopedic Equipment Company (K781443, K781448, K781449) Device Description The K2M Growing Spine System consists of screw and connector components. The purpose of th… | 1978 |
| * | K781448 | Harrington Hook ClampSummary page 5…9, K121630, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114) Orthopedic Equipment Company (K781443, K781448, K781449) Device Description The K2M Growing Spine System consists of screw and connector components. The purpose of this 510(k)… | 1978 |
| * | K781449 | Harrington Spinal ElevatorSummary page 5…0, K141873) DePuy ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) Stryker Xia® Growth Rod Conversion Set (K142114) Orthopedic Equipment Company (K781443, K781448, K781449) Device Description The K2M Growing Spine System consists of screw and connector components. The purpose of this 510(k) is to en… | 1978 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 29 of the 321 ancestors have a recall of any class.
- Of its descendants, K181068 (Globus Medical, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K133904.
How does its category compare?
All PGM devicesPGM Growing Rod System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The K2M Growing Spine System implants are indicated in patients with potential for additional spinal growth under 10 years of age 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. The Growth Guidance implants may be used with any cleared K2M rod construct ranging in diameter 4.5mm to 6.35mm. The Growth Rod Conversion implants may be used with 4.5mm and 5.5mm rod constructs. The K2M Growing Spine System is not intended to be used in conjunction with staples.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161028: K2M Growing Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161028
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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