510(k) · Cleared
Recalled · Class II · 2022MAGEC® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive Specialized Orthopedics, Inc. · PGN Growing Rod System- Magnetic Actuation
Cleared on Jul 30, 2020 as substantially equivalent to K171791 (Nuvasive Specialized Orthopedics, Incorporated, 2017) and 2 other predicates after a 51-day review. Its family tree reaches back 5 generations to 2014. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 30, 2020
- Review
- 51 days
- Class
- Class II
- Product code
- PGN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K140178 (2014). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK140178 Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014 · Recalled
- 4 generations backK140613 Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014
- 3 generations backK150885 MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015
- 2 generations backK161751 MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
- 1 generation backK171791 MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 2017 · Recalled
- This deviceK201543 MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK233593 MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024
Most influential descendants
Showing 1 of 1 · See all- K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K140178 | Ellipse Magec Spinal Bracing and Distraction System | Ellipse Technologies, Inc. | 2014 | 1 |
| −4 | K140613 | Magec Spinal Bracing and Distraction System | Ellipse Technologies, Inc. | 2014 | — |
| −3 | K150885 | MAGEC 2 Spinal Bracing and Distraction System | Ellipse Technologies, Incorporated | 2015 | — |
| −2 | K161751 | MAGEC® Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Inc. | 2016 | — |
| −1 | K171791 | MAGEC® System | Nuvasive Specialized Orthopedics, Incorporated | 2017 | 2 |
| 0 (this device) | K201543 | MAGEC® System | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +1 | K233593 | MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K171791 | MAGEC® SystemSummary page 5…duct Code: PGN C. Predicate Devices The subject device is substantially equivalent to the following devices: Primary Predicate x K171791 – MAGEC System Additional Predicates x K150885 – MAGEC 2 Spinal Bracing And Distraction System x K140178 – M… | 2017 |
| * | K150885 | MAGEC 2 Spinal Bracing and Distraction SystemSummary page 5…The subject device is substantially equivalent to the following devices: Primary Predicate x K171791 – MAGEC System Additional Predicates x K150885 – MAGEC 2 Spinal Bracing And Distraction System x K140178 – MAGEC Spinal Bracing And Distraction System D. Device Desc… | 2015 |
| * | K140178 | Ellipse Magec Spinal Bracing and Distraction SystemSummary page 5…g devices: Primary Predicate x K171791 – MAGEC System Additional Predicates x K150885 – MAGEC 2 Spinal Bracing And Distraction System x K140178 – MAGEC Spinal Bracing And Distraction System D. Device Description The MAGEC ® System is comprised of a sterile single u… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233593 | MAGEC Spinal Bracing and Distraction System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2022 | Class II | Z-0559-2023 | Process control | During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K233593 (Nuvasive Specialized Orthopedics, Incorporated, 2024) has gone furthest, with 0 descendants of its own.
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. 2020, 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 MAGEC® 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/K201543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201543: MAGEC® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201543
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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