510(k) Report

510(k) · Cleared

Cleared

CD Horizon Spinal System Growth Rod Set

K133904510(k) TraditionalCleared Feb 25, 201467-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

Medtronic Sofamor Danek USA · PGM Growing Rod System

Cleared on Feb 25, 2014 as substantially equivalent to K121764 (Medtronic Sofamor Danek, Inc., 2012) after a 67-day review. Its family tree reaches back 4 generations to 2002. 43 later devices descend from it.

Decided
Feb 25, 2014
Review
67 days
Class
Class II
Product code
PGM
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K013962 (2002). 6 ancestors in all, the oldest K961633 (1996). 43 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor2017: 1 descendant cleared2014: 4 descendants cleared2015: 1 descendant cleared2018: 2 descendants cleared2016: 1 descendant cleared2022: 2 descendants cleared2026: 13 descendants cleared2025: 5 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2024: 11 descendants clearedK013962 · Equation Fixation System · Medtronic Sofamor Danek, Inc. · 2002×2: 2 generations cleared close together, K042453 (2004), K042962 (2004) K121764 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 8 descendants3 generations forward: 5 descendants4 generations forward: 13 descendants5 generations forward: 6 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K121764 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2012K042962 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K042453 · Modification to Equation Fixation System · Medtronic Sofamor Danek, Inc. · 2004K013962 · Equation Fixation System · Medtronic Sofamor Danek, Inc. · 20020+5
  1. Root · 4 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  2. 3 generations backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
  3. 2 generations backK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  4. 1 generation backK121764 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
  5. This deviceK133904 CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
  6. Descendant · cites it directly · 27 of its ownK140750 Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc. · 2014
  7. Descendant · cites it directly · 24 of its ownK150200 CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated · 2015
  8. Descendant · 2 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
  9. Descendant · 3 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
  10. Descendant · cites it directly · 13 of its ownK142114 Xia® Growth Rod Conversion SetStryker Corporation · 2014

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2014: 42015: 12016: 12017: 12018: 22020: 12022: 22023: 22024: 112025: 52026: 13
2014high 13 (2026) · low 0 (2019)2026

Most influential descendants

Showing 5 of 43 · See all
  • K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly27descendants
  • K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated · 2015 · cites it directly24descendants
  • K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · 2 generations on20descendants
  • K223494CD Horizon Spinal SystemMedtronic · 2023 · 3 generations on17descendants
  • K142114Xia® Growth Rod Conversion SetStryker Corporation · 2014 · cites it directly13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K013962Equation Fixation SystemMedtronic Sofamor Danek, Inc.2002—
−3K042453Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc.2004—
−2K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−1K121764CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2012—
0 (this device)K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA2014—
+1K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.2014—
+1K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated2015—
+2K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD…Medtronic Sofamor Danek USA, Inc.2022—
+3K223494CD Horizon Spinal SystemMedtronic2023—
+1K142114Xia® Growth Rod Conversion SetStryker Corporation2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201440
201510
201610
201710
201820
202010
202220
202320
2024110
202550
2026130
FIG. 1 — Lineage of K133904, 2002–2026Source: 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 PGM? 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 PGM device

  1. #1 K251961 SDS Growing Rodscore 12.2 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K121764CD Horizon Spinal System
Summary page 6
…lly, the subject CD HORIZON® Growth Rod Conversion Set connectors are substantially equivalent to similar connectors previously cleared in the CD HORIZON® Spinal System (K121764, SE 08/21/12). No new implant materials, instruments or sterilization methods are being added to the system through this applica…
Medtronic Sofamor Danek, Inc.2012—
*—Harrington Spinal Rod System
Named without a submission number
—

Also cleared against K121764: 1 other device →

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.201427
K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated201524
K142114Xia® Growth Rod Conversion SetStryker Corporation201413
K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146
K161028K2M Growing Spine SystemK2m, Inc.20163
K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182
K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.20181
K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.20141
K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated20170

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 12 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K140750 (Medtronic Sofamor Danek USA, Inc., 2014) has gone furthest, with 27 descendants of its own.
  • 1 other device also cites its predicate K121764.

How does its category compare?

All PGM devices

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

FDA decisions per year · PGM

1in 2025

2014: 42015: 12016: 12017: 12018: 22019: 12020: 12022: 12025: 12026 (partial year): 1
2007high 4 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGM

81in 2014

2014: 81 days median
2007high 81 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PGM

No recall names PGM since 2007.

Adverse event reports per year · PGM

7in 2025

2014: 52015: 12016: 92017: 42018: 12020: 12022: 52023: 32024: 12025: 7
2007high 9 (2016) · low 0 (2007)2025

MAUDE reports naming product code PGM, 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
201448105
20151—01
20161—09
20171—04
20182—01
20191—00
20201—01
20210—00
20221—05
20230—03
20240—01
20251—07
20261—0—

What is it indicated for?

The CD HORIZON® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK rods, SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

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 K121764

1 other device cites the same predicate.

  • K123552Instinct Java SystemZimmer Spine · 20131 recall

More from Medtronic Sofamor Danek USA

9 FDA decisions under this applicant name. See the company

  • K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
  • K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
  • K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  • K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  • K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA · 2013

Recent decisions in PGM

The PGM category page

  • K251961SDS Growing RodBAAT Medical Products B.V. · 2026
  • K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp. · 2025
  • K213196MARVEL™ Growing RodsGlobus Medical, Inc. · 2022
  • K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation · 2020
  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019

https://510kreport.com/device/K133904 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133904: CD Horizon Spinal System Growth Rod Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133904

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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