510(k) · Cleared
ClearedGuided Growth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Cleared on Jun 10, 2010 as substantially equivalent to K031493 (University of Utah/School of Medicine, 2003) after a 217-day review. Its family tree reaches back 1 generation to 2003. 5 later devices descend from it.
- Decided
- Jun 10, 2010
- Review
- 217 days
- Class
- Class II
- Product code
- OBT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031493 (2003). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031493 Growth Guidance PlateUniversity of Utah/School of Medicine · 2003
- This deviceK093442 Guided Growth SystemOrthofix, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK172183 Guided Growth Plate System PlusOrthofix Srl · 2018
- Descendant · cites it directly · 1 of its ownK171173 OrthoPediatrics Titanium PediPlates® SystemOrthoPediatrics Corp. · 2017
- Descendant · cites it directly · 1 of its ownK110805 Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)Orthofix, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK182704 WishBone Guided Growth SystemWishbone Medical · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK180624 Guided Growth Plate System PlusOrthofix Srl · 2018
Most influential descendants
Showing 5 of 5 · See all- K172183Guided Growth Plate System PlusOrthofix Srl · 2018 · cites it directly1descendant
- K171173OrthoPediatrics Titanium PediPlates® SystemOrthoPediatrics Corp. · 2017 · cites it directly1descendant
- K110805Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)Orthofix, Inc. · 2011 · cites it directly1descendant
- K182704WishBone Guided Growth SystemWishbone Medical · 2019 · 2 generations on0descendants
- K180624Guided Growth Plate System PlusOrthofix Srl · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031493 | Growth Guidance Plate | University of Utah/School of Medicine | 2003 | — |
| 0 (this device) | K093442 | Guided Growth System | Orthofix, Inc. | 2010 | — |
| +1 | K172183 | Guided Growth Plate System Plus | Orthofix Srl | 2018 | — |
| +1 | K171173 | OrthoPediatrics Titanium PediPlates® System | OrthoPediatrics Corp. | 2017 | — |
| +1 | K110805 | Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel) | Orthofix, Inc. | 2011 | — |
| +2 | K182704 | WishBone Guided Growth System | Wishbone Medical | 2019 | 1 |
| +2 | K180624 | Guided Growth Plate System Plus | Orthofix Srl | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
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 OBT? 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 OBT device
- #1 K220190 The GIRO Growth Modulation Systemscore 5.1 · 4 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031493 | Growth Guidance PlateSummary page 1…eight-Plate®. The Orthofix Guided Growth System eight-Plate, manufactured by Orthofix Inc. of McKinney, Texas, was originally cleared by FDA under K031493 on November 20, 2003.… | 2003 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All OBT devicesOBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OBT
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OBT
Too few OBT 510(k)s in any year since 2007 to give a median.
Recalls per year · OBT
No recall names OBT since 2007.
Adverse event reports per year · OBT
2in 2025
MAUDE reports naming product code OBT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Guided Growth Plates are 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.
https://510kreport.com/device/K093442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093442: Guided Growth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093442
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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