510(k) · Cleared
ClearedIsola and Expedium Growing Spine Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos Sarl · PGM Growing Rod System
Cleared on Aug 22, 2014 as substantially equivalent to K133904 (Medtronic Sofamor Danek USA, 2014) and 3 other predicates after a 77-day review. Its family tree reaches back 5 generations to 2002. 6 later devices descend from it.
- Decided
- Aug 22, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- PGM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K013962 (2002). 10 ancestors in all, the oldest K922504 (1993). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
- 3 generations backK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK121764 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
- 1 generation backK133904 CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
- This deviceK141509 Isola and Expedium Growing Spine SystemsMedos Sarl · 2014
- Descendant · cites it directly · 3 of its ownK161028 K2M Growing Spine SystemK2m, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK142587 Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK233105 RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161028K2M Growing Spine SystemK2m, Inc. · 2016 · cites it directly3descendants
- K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018 · 2 generations on2descendants
- K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 2014 · cites it directly1descendant
- K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · 3 generations on0descendants
- K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013962 | Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K042453 | Modification to Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −3 | K042962 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K121764 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2012 | — |
| −1 | K133904 | CD Horizon Spinal System Growth Rod Set | Medtronic Sofamor Danek USA | 2014 | — |
| 0 (this device) | K141509 | Isola and Expedium Growing Spine Systems | Medos Sarl | 2014 | — |
| +1 | K161028 | K2M Growing Spine System | K2m, Inc. | 2016 | — |
| +2 | K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018 | — |
| +1 | K142587 | Vertical Expandable Prosthetic Titanium Rib | Depuy Synthes Spine, Inc. | 2014 | 1 |
| +3 | K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System… | Globus Medical, Inc. | 2026 | — |
| +2 | K233105 | RESPONSE™ Rib and Pelvic System | OrthoPediatrics Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (5)
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…PredicateDeviceName Tradename: MedtronicCDHorizon®GrowthRodConversionSet (K133904) EXPEDIUMSpineSystem(K111136)… | 2014 |
| * | K111136 | Expedium Spine System, Viper System, Viper 2 SystemSummary page 5…icCDHorizon®GrowthRodConversionSet (K133904) EXPEDIUMSpineSystem(K111136) ISOLASpineSystem(K980485) Har… | 2012 |
| * | K980485 | Isola Spinal SystemSummary page 5…(K133904) EXPEDIUMSpineSystem(K111136) ISOLASpineSystem(K980485) HarringtonSpinalRodSystem(PreͲAmendment) E. DeviceDescription… | 1998 |
| * | K922504 | Isola (R) Tandem ConnectorSummary page 6…ditionally, the subjectextendedtandemconnectorsaresubstantiallyequivalenttotandemconnectors previouslyclearedintheISOLASpineSystem(K922504,K980485).Thesubjectdevices aresimilarinmaterials,manufacturing,andsterilizationasthepreviouslyclearedIS… | 1993 |
| * | — | Harrington Spinal Rod System (Pre-Amendment) Named without a submission number |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K161028 (K2m, Inc., 2016) has gone furthest, with 3 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. 2014, 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 ISOLA® Growing Spine System is indicated for 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 ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs. The…
Read the full statement (138 words)
The ISOLA® Growing Spine System is indicated for 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 ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs.
The EXPEDIUM® Growing Spine System is indicated for 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 EXPEDIUM® Growing Spine System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM® Spine Systems. The EXPEDIUM® Growing Spine System is not intended to be used with 4.0mm diameter screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141509: Isola and Expedium Growing Spine Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141509
Report an extraction error
Are you the manufacturer?
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