510(k) Report

510(k) · Cleared

Cleared

Xia® Growth Rod Conversion Set

K142114510(k) TraditionalCleared Oct 27, 201484-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

Stryker Corporation · PGM Growing Rod System

Cleared on Oct 27, 2014 as substantially equivalent to K133904 (Medtronic Sofamor Danek USA, 2014) after an 84-day review. Its family tree reaches back 5 generations to 2002. 13 later devices descend from it.

Decided
Oct 27, 2014
Review
84 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). 13 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2024: 4 descendants cleared2022: 1 descendant cleared2026: 3 descendants clearedReference device: K121342 · Xia 4.5 Spinal System · Stryker Corp. · 2012K013962 · 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: 4 descendants3 generations forward: 5 descendants 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
  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 deviceK142114 Xia® Growth Rod Conversion SetStryker Corporation · 2014
  7. Descendant · cites it directly · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
  8. Descendant · cites it directly · 3 of its ownK161028 K2M Growing Spine SystemK2m, Inc. · 2016
  9. Descendant · cites it directly · 2 of its ownK193224 Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation · 2020
  10. Descendant · 2 generations on · 2 of its ownK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
  11. Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12018: 12020: 12022: 12023: 12024: 42026: 3
2016high 4 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 13 · See all
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · cites it directly4descendants
  • K161028K2M Growing Spine SystemK2m, Inc. · 2016 · cites it directly3descendants
  • K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation · 2020 · cites it directly2descendants
  • K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018 · 2 generations on2descendants
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
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)K142114Xia® Growth Rod Conversion SetStryker Corporation2014—
+1K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System…Stryker Spine2023—
+1K161028K2M Growing Spine SystemK2m, Inc.2016—
+1K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation2020—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.2018—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201810
202010
202210
202310
202440
202630
FIG. 1 — Lineage of K142114, 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? (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
*K133904CD Horizon Spinal System Growth Rod Set
Summary page 5
…equivalent to the primary predicate device listed below: Medtronic Sofamor Danek, CD HORIZON® Growth Rod Conversion Set, K133904 The following reference device was also cited in support of this submission:…
Medtronic Sofamor Danek USA2014—
†K121342Xia 4.5 Spinal SystemStryker Corp.2012—

Also cleared against K133904: 8 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234
K161028K2M Growing Spine SystemK2m, Inc.20163
K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation20202
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 4 companies; a new generation was cleared every 1.5 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K222684 (Stryker Spine, 2023) has gone furthest, with 4 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 Xia® 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 Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples.

Indications for use as stated in the FDA summary.

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 Stryker Corporation

87 FDA decisions under this applicant name. See the company

  • K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice…Stryker Corporation · 2023
  • K223770Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023
  • K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker…Stryker Corporation · 20232 recalls
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating…Stryker Corporation · 2022
  • K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022

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/K142114 · printed Nov 3, 2026

Cite this page

510(k) Report. “K142114: Xia® Growth Rod Conversion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142114

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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