510(k) · Cleared
ClearedThe GIRO Growth Modulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pega Medical, Inc. · OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Cleared on Oct 24, 2022 as substantially equivalent to K090440 (Pega Medical, Inc., 2009) and 1 other predicate after a 273-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Oct 24, 2022
- Review
- 273 days
- Class
- Class II
- Product code
- OBT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K993106 (1999). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK993106 Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and…Smith & Nephew, Inc. · 1999
- 3 generations backK073344 Orthopediatrics Plating SystemOrthopediatrics, LLC · 2008
- 2 generations backK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
- 1 generation backK090440 Hinge Pediatric Plating SystemPega Medical, Inc. · 2009
- This deviceK220190 The GIRO Growth Modulation SystemPega Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) | Smith & Nephew, Inc. | 1999 | — |
| −3 | K073344 | Orthopediatrics Plating System | Orthopediatrics, LLC | 2008 | — |
| −2 | K081407 | Orthopediatrics Pediplates System | OrthoPediatrics Corp. | 2008 | — |
| −1 | K090440 | Hinge Pediatric Plating System | Pega Medical, Inc. | 2009 | — |
| 0 (this device) | K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K090440 | Hinge Pediatric Plating SystemSummary page 4…Primary Predicate Hinge Pediatric Plating Pega Medical Inc. 80588 K090440 device System Additional PediatrOS Merete Medical… | 2009 |
| * | K151762 | PediatrOS RigidTack/FlexTackSummary page 4…PediatrOS Merete Medical N/A K151762 Predicate device RigidTack/Flextack GMBH OrthoPediatrics… | 2015 |
| † | K090666 | Pediplates | 2009 |
| † | K110805 | Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel) | 2011 |
| † | K834513 | Fixation Staples | 1984 |
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 23 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
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. 2022, 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 GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for the following conditions:
Femur and tibia: varus, valgus, flexion, or extension deformities of the knee.
Humerus: valgus or varus deformities of the elbow.
Radius and ulna: flexion or extension deformities of the wrist.
Ankle: varus, valgus or plantar flexion deformities of the ankle.
Limb length discrepancy of the femur and tibia.
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/K220190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220190: The GIRO Growth Modulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220190
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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