510(k) · Cleared
ClearedGuided Growth Plate System Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Cleared on May 15, 2018 as substantially equivalent to K172183 (Orthofix Srl, 2018) after a 67-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- May 15, 2018
- Review
- 67 days
- Class
- Class II
- Product code
- OBT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K031493 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK031493 Growth Guidance PlateUniversity of Utah/School of Medicine · 2003
- 2 generations backK093442 Guided Growth SystemOrthofix, Inc. · 2010
- 1 generation backK172183 Guided Growth Plate System PlusOrthofix Srl · 2018
- This deviceK180624 Guided Growth Plate System PlusOrthofix Srl · 2018
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K172183 | Guided Growth Plate System PlusSummary page 4…3030 Product Code OBT Name of Predicate Device 510(k) # Manufacturer Guided Growth Plate System Plus K172183 Orthofix Srl Fixation staples K834513 STRYKER CORP. - Blount Stapl… | 2018 |
| † | K834513 | Fixation Staples | 1984 |
| † | K140431 | Pediloc Fragment System | 2014 |
| † | K031493 | Growth Guidance Plate | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
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. 2018, 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 Plate System Plus is intended for redirecting the growth of long bones.
It is indicated for gradually correcting angular growth 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), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180624: Guided Growth Plate System Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180624
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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