510(k) Report

510(k) · Cleared

Cleared

MAGEC Spinal Bracing and Distraction System

K233593510(k) TraditionalCleared Feb 6, 202490-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

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

Cleared on Feb 6, 2024 as substantially equivalent to K201543 (Nuvasive Specialized Orthopedics, Inc., 2020) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 2014.

Decided
Feb 6, 2024
Review
90 days
Class
Class II
Product code
PGN
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K140178 (2014). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestorK140178 · 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. · 2016K171791 · MAGEC® System · Nuvasive Specialized Orthopedics, Incorporated · 2017 · recalledK201543 · MAGEC® System · Nuvasive Specialized Orthopedics, Inc. · 2020 · recalled2010201520202025
Other ancestors, by generation 3 generations back: 1 other ancestor K201543 · MAGEC® System · Nuvasive Specialized Orthopedics, Inc. · 2020 · recalledK171791 · MAGEC® System · Nuvasive Specialized Orthopedics, Incorporated · 2017 · recalledK161751 · 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 · recalled−50
  1. Root · 6 generations backK140178 Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014 · Recalled
  2. 5 generations backK140613 Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014
  3. 4 generations backK150885 MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015
  4. 3 generations backK161751 MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc. · 2016
  5. 2 generations backK171791 MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 2017 · Recalled
  6. 1 generation backK201543 MAGEC® SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
  7. This deviceK233593 MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K140178Ellipse Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc.20141
−5K140613Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc.2014—
−4K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated2015—
−3K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.2016—
−2K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated20172
−1K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.20201
0 (this device)K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K233593, 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 K201543 MAGEC® Systemscore 2.0 · 5 generations · no Class I recall
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K201543MAGEC® System
Summary page 4
…PGN C. Predicate Devices The subject MAGEC Spinal Bracing and Distraction System is substantially equivalent to the primary predicate MAGEC® System (K201543) and additional predicates MAGEC® Spinal Bracing and Distraction System (K161751) and Magec Spinal Bracing And Distraction S…
Nuvasive Specialized Orthopedics, Inc.20201
*K161751MAGEC® Spinal Bracing and Distraction System
Summary page 4
…ion System is substantially equivalent to the primary predicate MAGEC® System (K201543) and additional predicates MAGEC® Spinal Bracing and Distraction System (K161751) and Magec Spinal Bracing And Distraction System (K140613). D. Device Description The subject MAGEC Spinal Bracing a…
Nuvasive Specialized Orthopedics, Inc.2016—
*K140613Magec Spinal Bracing and Distraction System
Summary page 4
…icate MAGEC® System (K201543) and additional predicates MAGEC® Spinal Bracing and Distraction System (K161751) and Magec Spinal Bracing And Distraction System (K140613). D. Device Description The subject MAGEC Spinal Bracing and Distraction System has an identical design and principle…
Ellipse Technologies, Inc.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?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 7 ancestors have a recall of any class.

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. 2024, 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 Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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.

More from Nuvasive Specialized Orthopedics…

4 FDA decisions under this applicant name. See the company

  • K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated · 20231 recall
  • K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated · 20172 recalls
  • K170939Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated · 2017

Recent decisions in PGN

The PGN category page

  • 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
  • K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated · 2015

https://510kreport.com/device/K233593 · printed Nov 5, 2026

Cite this page

510(k) Report. “K233593: MAGEC Spinal Bracing and Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233593

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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