510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

MAGEC® System

K171791510(k) TraditionalCleared Aug 31, 201776-day reviewClass II21 CFR 888.3070Recalls 2

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

Nuvasive Specialized Orthopedics, Incorporated · PGN Growing Rod System- Magnetic Actuation

Cleared on Aug 31, 2017 as substantially equivalent to K150885 (Ellipse Technologies, Incorporated, 2015) and 3 other predicates after a 76-day review. Its family tree reaches back 4 generations to 2014. 2 later devices descend from it. It has been recalled 2 times.

Decided
Aug 31, 2017
Review
76 days
Class
Class II
Product code
PGN
Recalls
2
Predicates
4

Its longest line of descent runs back 4 generations to K140178 (2014). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 1 other ancestor2020: 1 descendant cleared2024: 1 descendant clearedK140178 · Ellipse Magec Spinal Bracing and Distraction System · Ellipse Technologies, Inc. · 2014 · recalledK140613 · Magec Spinal Bracing and Distraction System · Ellipse Technologies, Inc. · 2014K150885 · MAGEC 2 Spinal Bracing and Distraction System · Ellipse Technologies, Incorporated · 2015K161751 · MAGEC® Spinal Bracing and Distraction System · Nuvasive Specialized Orthopedics, Inc. · 20162010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K161751 · MAGEC® Spinal Bracing and Distraction System · Nuvasive Specialized Orthopedics, Inc. · 2016K150885 · MAGEC 2 Spinal Bracing and Distraction System · Ellipse Technologies, Incorporated · 2015K140613 · Magec Spinal Bracing and Distraction System · Ellipse Technologies, Inc. · 2014K140178 · Ellipse Magec Spinal Bracing and Distraction System · Ellipse Technologies, Inc. · 2014 · recalled0
  1. Root · 4 generations backK140178 Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014 · Recalled
  2. 3 generations backK140613 Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014
  3. 2 generations backK150885 MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015
  4. 1 generation backK161751 MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  5. This deviceK171791 MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 2017
  6. Descendant · cites it directly · 1 of its ownK201543 MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
  7. Descendant · 2 generations on · 0 of its ownK233593 MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024

Most influential descendants

Showing 2 of 2 · See all
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−4K140178Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc.20141
−3K140613Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc.2014—
−2K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated2015—
−1K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.2016—
0 (this device)K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated2017—
+1K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.20201
+2K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202410
FIG. 1 — Lineage of K171791, 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
Get a 510(k) Report

What was it cleared against? (4)

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
*K150885MAGEC 2 Spinal Bracing and Distraction System
Summary page 5
…Actuation C. Predicate Devices The subject device is substantially equivalent to the primary predicate device MAGEC 2 Spinal Bracing and Distraction System (K150885) and additional predicate devices MAGEC Spinal Bracing and Distraction System (K161751, K160352, and K140178). D. Device D…
Ellipse Technologies, Incorporated2015—
*K161751MAGEC® Spinal Bracing and Distraction System
Summary page 5
…primary predicate device MAGEC 2 Spinal Bracing and Distraction System (K150885) and additional predicate devices MAGEC Spinal Bracing and Distraction System (K161751, K160352, and K140178). D. Device Description The MAGEC System is comprised of a sterile single use spinal rod that can be…
Nuvasive Specialized Orthopedics, Inc.2016—
*K160352MAGEC® Spinal Bracing and Distraction System
Summary page 5
…predicate device MAGEC 2 Spinal Bracing and Distraction System (K150885) and additional predicate devices MAGEC Spinal Bracing and Distraction System (K161751, K160352, and K140178). D. Device Description The MAGEC System is comprised of a sterile single use spinal rod that can be surgical…
Nuvasive Specialized Orthopedics, Inc.2016—
*K140178Ellipse Magec Spinal Bracing and Distraction System
Summary page 5
…ice MAGEC 2 Spinal Bracing and Distraction System (K150885) and additional predicate devices MAGEC Spinal Bracing and Distraction System (K161751, K160352, and K140178). D. Device Description The MAGEC System is comprised of a sterile single use spinal rod that can be surgically impla…
Ellipse Technologies, Inc.20141

Also cleared against K150885: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.20201

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 3, 2025Class IIZ-1657-2025Nonconforming Material/ComponentDevices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
Feb 13, 2020Class IIZ-1898-2020Process controlPost-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 12 months on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K201543 (Nuvasive Specialized Orthopedics, Inc., 2020) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K150885.

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. 2017, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K150885

3 other devices cite the same predicate.

  • K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 20201 recall
  • K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  • K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016

More from Nuvasive Specialized Orthopedics…

4 FDA decisions under this applicant name. See the company

  • K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024
  • K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated · 20231 recall
  • K170939Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated · 2017

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
  • K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  • K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  • K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015

https://510kreport.com/device/K171791 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171791: 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/K171791

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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