510(k) · Cleared
ClearedMagec Spinal Bracing and Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellipse Technologies, Inc. · PGN Growing Rod System- Magnetic Actuation
Cleared on Mar 24, 2015 as substantially equivalent to K140178 (Ellipse Technologies, Inc., 2014) after a 312-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Mar 24, 2015
- Review
- 312 days
- Class
- Class II
- Product code
- PGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K140178 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK140178 Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014 · Recalled
- This deviceK141278 Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K140178 | Ellipse Magec Spinal Bracing and Distraction System | Ellipse Technologies, Inc. | 2014 | 1 |
| 0 (this device) | K141278 | Magec Spinal Bracing and Distraction System | Ellipse Technologies, Inc. | 2015 | — |
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 PGN? 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 PGN device
- #1 K233593 MAGEC Spinal Bracing and Distraction Systemscore 8.3 · 6 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K140178 | Ellipse Magec Spinal Bracing and Distraction SystemSummary page 5…ame: Unclassified (Product Code PGN, Growing Rod System — Magnetic Actuation) Predicate Device: Ellipse Technologies, Inc. MAGEC® Spinal Bracing and Distraction System, K140178 Product Description: The Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System is comprised of a sterile single… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K140178.
How does its category compare?
All PGN devicesPGN Growing Rod System- Magnetic Actuation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PGN
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PGN
Too few PGN 510(k)s in any year since 2007 to give a median.
Recalls per year · PGN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGN
4in 2025
MAUDE reports naming product code PGN, 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 | 2 | — | 0 | 12 |
| 2015 | 2 | — | 0 | 16 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 1 | — | 0 | 31 |
| 2018 | 0 | — | 0 | 45 |
| 2019 | 0 | — | 1 | 86 |
| 2020 | 1 | — | 0 | 339 |
| 2021 | 0 | — | 0 | 204 |
| 2022 | 0 | — | 1 | 120 |
| 2023 | 0 | — | 0 | 189 |
| 2024 | 1 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ellipse MAGEC Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
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/K141278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141278: Magec Spinal Bracing and Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141278
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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