510(k) · Cleared
Recalled · Class II · 2022PediatrOS RigidTack/FlexTack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · JDR Staple, Fixation, Bone
Cleared on Dec 28, 2015 as substantially equivalent to K031493 (University of Utah/School of Medicine, 2003) after a 182-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 28, 2015
- Review
- 182 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031493 (2003). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K220190The GIRO Growth Modulation SystemPega Medical, Inc. · 2022 · cites it directly0descendants
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) | K151762 | PediatrOS RigidTack/FlexTack | Merete Medical GmbH | 2015 | — |
| +1 | K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K031493 | Growth Guidance PlateSummary page 4…JDR Subsequent Product Code: OBT Proposed Regulatory Class: Class II Legally marketed Devices to which substantial Equivalence is claimed: K031493 Guided Growth Plate, UNIVERSITY OF UTAH/SCHOOL OF MEDICINE - Blount Zimmalloy staple, Zimmer Inc. Warsaw,… | 2003 |
| * | — | Blount Zimmalloy staple Named without a submission number |
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 |
|---|---|---|---|
| K220190 | The GIRO Growth Modulation System | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 18, 2022 | Class II | Z-0650-2022 | Error in labeling | Incorrect marketing label (25 mm) was applied to product size 20 mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The PediatrOSTM RigidTackTM / FlexTackTM bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOSTM RigidTackTM / FlexTackTM is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents.
Specific pediatric conditions/diseases for which the devices will be indicated include:
x Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia)
x Valgus or varus deformities of the elbow (humerus)
x Leg length discrepancies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151762: PediatrOS RigidTack/FlexTack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151762
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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