510(k) · Cleared
ClearedMAGEC 2 Spinal Bracing and Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellipse Technologies, Incorporated · PGN Growing Rod System- Magnetic Actuation
Cleared on May 29, 2015 as substantially equivalent to K140613 (Ellipse Technologies, Inc., 2014) after a 57-day review. Its family tree reaches back 2 generations to 2014. 5 later devices descend from it.
- Decided
- May 29, 2015
- Review
- 57 days
- Class
- Class II
- Product code
- PGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K140178 (2014). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK140178 Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014 · Recalled
- 1 generation backK140613 Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014
- This deviceK150885 MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015
- Descendant · cites it directly · 3 of its ownK160352 MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK161751 MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171791 MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK201543 MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK233593 MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024
Most influential descendants
Showing 5 of 5 · See all- K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016 · cites it directly3descendants
- K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016 · cites it directly3descendants
- K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 2017 · cites it directly2descendants
- K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 2020 · cites it directly1descendant
- K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K140178 | Ellipse Magec Spinal Bracing and Distraction System | Ellipse Technologies, Inc. | 2014 | 1 |
| −1 | K140613 | Magec Spinal Bracing and Distraction System | Ellipse Technologies, Inc. | 2014 | — |
| 0 (this device) | K150885 | MAGEC 2 Spinal Bracing and Distraction System | Ellipse Technologies, Incorporated | 2015 | — |
| +1 | K160352 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016 | — |
| +1 | K161751 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016 | — |
| +1 | K171791 | MAGEC® System | Nuvasive Specialized Orthopedics, Incorporated | 2017 | 2 |
| +1 | K201543 | MAGEC® System | Nuvasive Specialized Orthopedics, Inc. | 2020 | 1 |
| +2 | K233593 | MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K140613 | Magec Spinal Bracing and Distraction SystemSummary page 5…ied (Product Code PGN, Growing Rod System – Magnetic Actuation) 5. Primary Predicate: MAGEC Spinal Bracing and Distraction System, K140613 6. Product Description: The MAGEC 2 Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod t… | 2014 |
What descends from it? (5)
4 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 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K160352 (Nuvasive Specialized Orthopedics, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K140613.
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 2 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 as stated in the FDA summary.
https://510kreport.com/device/K150885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150885: MAGEC 2 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/K150885
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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