510(k) · Cleared
ClearedGuided Growth System Eight-Plate, Quad-Plate (Stainless Steel)
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 21, 2011 as substantially equivalent to K031493 (University of Utah/School of Medicine, 2003) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Jun 21, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- OBT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K031493 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK031493 Growth Guidance PlateUniversity of Utah/School of Medicine · 2003
- 1 generation backK093442 Guided Growth SystemOrthofix, Inc. · 2010
- This deviceK110805 Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)Orthofix, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK182704 WishBone Guided Growth SystemWishbone Medical · 2019 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K182704WishBone Guided Growth SystemWishbone Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031493 | Growth Guidance Plate | University of Utah/School of Medicine | 2003 | — |
| −1 | K093442 | Guided Growth System | Orthofix, Inc. | 2010 | — |
| 0 (this device) | K110805 | Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel) | Orthofix, Inc. | 2011 | — |
| +1 | K182704 | WishBone Guided Growth System | Wishbone Medical | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031493 | Growth Guidance Plate Our reading of the summary gave K031439, FDA’s number for Alginate Impression Material Iii (Fast & Regular) (Harry J. Bosworth Co.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Growth Guidance Plate (eight-Plate)”. | 2003 |
| * | K093442 | Guided Growth SystemSummary page 1…c, epiphysiodesis Legally Marketed Predicate Devices: Growth Guidance Plate (eight-Plate) K031439/111-20-03 Guided Growth System (quad-Plate) K093442/ 06-10-10 Device Description: The Guided Growth System is designed for the gradual correction of pedia… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182704 | WishBone Guided Growth System | 2019 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182704 (Wishbone Medical, 2019) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K031493.
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. 2011, 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, vanjs or flexion; extension deformities of the knee (femur and/or tibia), valgus, vanis or plantar fiexion deformities of the ankle, valgus or vanis 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/K110805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110805: Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110805
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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