510(k) Report

510(k) · Cleared

Cleared

Magec Spinal Bracing and Distraction System

K140613510(k) TraditionalCleared Sep 18, 2014192-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ellipse Technologies, Inc. · PGN Growing Rod System- Magnetic Actuation

Cleared on Sep 18, 2014 as substantially equivalent to K140178 (Ellipse Technologies, Inc., 2014) after a 192-day review. Its family tree reaches back 1 generation to 2014. 6 later devices descend from it.

Decided
Sep 18, 2014
Review
192 days
Class
Class II
Product code
PGN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K140178 (2014). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared2015: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant clearedK140178 · Ellipse Magec Spinal Bracing and Distraction System · Ellipse Technologies, Inc. · 2014 · recalled2010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants K140178 · Ellipse Magec Spinal Bracing and Distraction System · Ellipse Technologies, Inc. · 2014 · recalled0
  1. Root · 1 generation backK140178 Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014 · Recalled
  2. This deviceK140613 Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014
  3. Descendant · cites it directly · 5 of its ownK150885 MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015
  4. Descendant · 2 generations on · 3 of its ownK160352 MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  5. Descendant · 2 generations on · 3 of its ownK161751 MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  6. Descendant · 2 generations on · 2 of its ownK171791 MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 2017 · Recalled
  7. Descendant · 2 generations on · 1 of its ownK201543 MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2015: 12016: 22017: 12020: 12024: 1
2015high 2 (2016) · low 0 (2018)2026

Most influential descendants

Showing 5 of 6 · See all
  • K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015 · cites it directly5descendants
  • K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016 · 2 generations on3descendants
  • K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016 · 2 generations on3descendants
  • K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 2017 · 2 generations on2descendants
  • K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K140178Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc.20141
0 (this device)K140613Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc.2014—
+1K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated2015—
+2K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.2016—
+2K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.2016—
+2K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated20172
+2K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.20201

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201620
201710
202010
202410
FIG. 1 — Lineage of K140613, 2014–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233593 MAGEC Spinal Bracing and Distraction Systemscore 8.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K140178Ellipse Magec Spinal Bracing and Distraction System
Summary page 6
…the MAGEC System with the 70 mm Actuator rod is substantially equivalent to the following 510(k) cleared device: x MAGEC Spinal Bracing and Distraction System (K140178) Substantial equivalence to the predicate device is based on indications for use, principles of operation, technological characte…
Ellipse Technologies, Inc.20141

Also cleared against K140178: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated20155
K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated20240

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.
  • Of its descendants, K150885 (Ellipse Technologies, Incorporated, 2015) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K140178.

How does its category compare?

All PGN devices

PGN Growing Rod System- Magnetic Actuation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · PGN

1in 2024

2014: 22015: 22016: 22017: 12020: 12024: 1
2007high 2 (2014) · low 0 (2007)2026

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

2019: 12022: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PGN

4in 2025

2014: 122015: 162016: 182017: 312018: 452019: 862020: 3392021: 2042022: 1202023: 1892024: 302025: 4
2007high 339 (2020) · low 0 (2007)2025

MAUDE reports naming product code PGN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20142—012
20152—016
20162—018
20171—031
20180—045
20190—186
20201—0339
20210—0204
20220—1120
20230—0189
20241—030
20250—04
20260—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 as stated in the FDA summary.

Also cleared against K140178

3 other devices cite the same predicate.

  • K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 20201 recall
  • K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 20172 recalls
  • K141278Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2015

More from Ellipse Technologies, Inc.

13 FDA decisions under this applicant name. See the company

  • K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
  • K141278Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2015
  • K141739Residual Limb Lengthening SystemEllipse Technologies, Inc. · 20142 recalls
  • K141447Precice Trauma Nail SystemEllipse Technologies, Inc. · 2014
  • K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014

Recent decisions in PGN

The PGN category page

  • K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024
  • K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 20201 recall
  • K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 20172 recalls
  • K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  • K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016

https://510kreport.com/device/K140613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140613: 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/K140613

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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