510(k) Report

510(k) · Cleared

Cleared

Growth Guidance Plate

K031493510(k) TraditionalCleared Nov 20, 2003192-day reviewClass II21 CFR 888.3030

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

University of Utah/School of Medicine · HRS Plate, Fixation, Bone

Cleared on Nov 20, 2003 after a 192-day review. The FDA summary names its predicate without a number. 74 later devices descend from it.

Decided
Nov 20, 2003
Review
192 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

74 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2010: 4 descendants cleared2015: 2 descendants cleared2009: 3 descendants cleared2011: 3 descendants cleared2007: 1 descendant cleared2008: 1 descendant cleared2022: 4 descendants cleared2019: 5 descendants cleared2018: 5 descendants cleared2017: 7 descendants cleared2014: 1 descendant cleared2012: 1 descendant cleared2020: 6 descendants cleared2026: 6 descendants cleared2025: 8 descendants cleared2016: 1 descendant cleared2023: 5 descendants cleared2024: 10 descendants cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK031493 Growth Guidance PlateUniversity of Utah/School of Medicine · 2003
  2. Descendant · cites it directly · 65 of its ownK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
  3. Descendant · 2 generations on · 60 of its ownK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
  4. Descendant · 3 generations on · 28 of its ownK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
  5. Descendant · cites it directly · 15 of its ownK090666 PediplatesOrthoPediatrics Corp. · 2009
  6. Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 32010: 42011: 32012: 12014: 12015: 22016: 12017: 72018: 52019: 52020: 62021: 12022: 42023: 52024: 102025: 82026: 6
2007high 10 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 74 · See all
  • K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008 · cites it directly65descendants
  • K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · 2 generations on60descendants
  • K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012 · 3 generations on28descendants
  • K090666PediplatesOrthoPediatrics Corp. · 2009 · cites it directly15descendants
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031493Growth Guidance PlateUniversity of Utah/School of Medicine2003—
+1K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp.2008—
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.20095
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC2012—
+1K090666PediplatesOrthoPediatrics Corp.2009—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200930
201040
201130
201210
201410
201520
201610
201770
201850
201950
202060
202110
202240
202350
2024100
202580
202660
FIG. 1 — Lineage of K031493, 2003–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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
*—Blount Zimmalloy staple
Named without a submission number
—

What descends from it? (74)

See all 74

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

NumberDeviceApplicantDecidedDescendants
K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp.200865
K090666PediplatesOrthoPediatrics Corp.200915
K093442Guided Growth SystemOrthofix, Inc.20105
K070823Growth Control Plating SystemBiomet Trauma20073
K151762PediatrOS RigidTack/FlexTackMerete Medical GmbH20151
K110805Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)Orthofix, Inc.20111
K090440Hinge Pediatric Plating SystemPega Medical, Inc.20091
K093880Peanut Growth Control Plating SystemEbi, L.P.20100

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?

  • Of its descendants, K081407 (OrthoPediatrics Corp., 2008) has gone furthest, with 65 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The Guided Growth Plate is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children.

Specific conditions/diseases for which the device will be indicated include:

*valgus, varus or flexion extension deformities of the knee (femur and/or tibia)

*valgus, varus or plantar flexion deformities of the ankle

*valgus or varus deformities of the elbow (humerus)

*radial or ulnar deviation, flexion or extension deformities of the wrist (radius)

Indications for use as stated in the FDA summary.

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K031493 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031493: Growth Guidance Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031493

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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