510(k) Report

510(k) · Cleared

Cleared

Shilla Growth Guidance System

K140750510(k) TraditionalCleared Jul 17, 2014114-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, Inc. · PGM Growing Rod System

Cleared on Jul 17, 2014 as substantially equivalent to K133904 (Medtronic Sofamor Danek USA, 2014) after a 114-day review. Its family tree reaches back 5 generations to 2002. 27 later devices descend from it.

Decided
Jul 17, 2014
Review
114 days
Class
Class II
Product code
PGM
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K013962 (2002). 7 ancestors in all, the oldest K961633 (1996). 27 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor2022: 2 descendants cleared2026: 11 descendants cleared2025: 5 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2024: 6 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. · 2012K133904 · CD Horizon Spinal System Growth Rod Set · Medtronic Sofamor Danek USA · 20141995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 12 descendants4 generations forward: 6 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K133904 · CD Horizon Spinal System Growth Rod Set · Medtronic Sofamor Danek USA · 2014K121764 · 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. · 2002−50+5
  1. Root · 5 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  2. 4 generations backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
  3. 3 generations backK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  4. 2 generations backK121764 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2012
  5. 1 generation backK133904 CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
  6. This deviceK140750 Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc. · 2014
  7. Descendant · cites it directly · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
  8. Descendant · 2 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
  9. Descendant · 3 generations on · 5 of its ownK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
  10. Descendant · 3 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
  11. Descendant · 4 generations on · 3 of its ownK243007 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2024

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2016: 12018: 12022: 22023: 12024: 62025: 52026: 11
2016high 11 (2026) · low 0 (2017)2026

Most influential descendants

Showing 5 of 27 · See all
  • K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · cites it directly20descendants
  • K223494CD Horizon Spinal SystemMedtronic · 2023 · 2 generations on17descendants
  • K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc. · 2024 · 3 generations on5descendants
  • K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 3 generations on5descendants
  • K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2024 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K013962Equation Fixation SystemMedtronic Sofamor Danek, Inc.2002—
−4K042453Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc.2004—
−3K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−2K121764CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2012—
−1K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA2014—
0 (this device)K140750Shilla Growth Guidance SystemMedtronic Sofamor Danek USA, Inc.2014—
+1K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD…Medtronic Sofamor Danek USA, Inc.2022—
+2K223494CD Horizon Spinal SystemMedtronic2023—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.2024—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.2024—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
202220
202310
202460
202550
2026110
FIG. 1 — Lineage of K140750, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K133904CD Horizon Spinal System Growth Rod Set
Summary page 6
…e 2 of 2 Identification of Legally Marketed Devices: The subject SHILLA™ Growth Guidance System is substantially equivalent to the CD HORIZON® Growth Rod Conversion Set K 133904 (1/30/14) and to the pre-amendment Harrington Rod Spinal System. Discussion of Supporting Retrospective Clinical Data and Non-Cl…
Medtronic Sofamor Danek USA2014—
*—Harrington Rod Spinal System
Named without a submission number
—

Also cleared against K133904: 8 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220
K161028K2M Growing Spine SystemK2m, Inc.20163
K251961SDS Growing RodBAAT Medical Products B.V.20260
K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.20250

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 4 companies; a new generation was cleared every 1.5 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K221646 (Medtronic Sofamor Danek USA, Inc., 2022) has gone furthest, with 20 descendants of its own.
  • 8 other devices also cite its predicate K133904.

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 SHILLA™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The SHILLA™ Growth Guidance System is intended to be removed after skeletal maturity.

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 K133904

8 other devices cite the same predicate.

  • K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
  • K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc. · 2018
  • K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated · 2017
  • K161028K2M Growing Spine SystemK2m, Inc. · 2016
  • K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated · 2015
  • K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 20141 recall

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

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/K140750 · printed Nov 5, 2026

Cite this page

510(k) Report. “K140750: Shilla Growth Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140750

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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