510(k) · Cleared
ClearedPediFlex™ Flexible Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · HTY Pin, Fixation, Smooth
Cleared on Jun 24, 2025 as substantially equivalent to K201838 (OrthoPediatrics Corp., 2021) after a 54-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Jun 24, 2025
- Review
- 54 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960642 (1996). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK960642 Nancy NailLandos, Inc. · 1996
- 5 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 4 generations backK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
- 3 generations backK081097 Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC · 2008
- 2 generations backK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
- 1 generation backK201838 PediFlex Flexible Nail SystemOrthoPediatrics Corp. · 2021
- This deviceK251362 PediFlex™ Flexible Nail SystemOrthoPediatrics Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −5 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −4 | K032687 | Ace Nancy Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| −3 | K081097 | Orthopediatrics Pediflex Flexible Nail System | Orthopediatrics, LLC | 2008 | — |
| −2 | K082375 | Orthopediatrics Pediflex Flexible Nail System | OrthoPediatrics Corp. | 2008 | — |
| −1 | K201838 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | 2021 | — |
| 0 (this device) | K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K201838 | PediFlex Flexible Nail SystemSummary page 5…e Device and Reference Device Substantial equivalence is claimed to the following predicate devices: Primary Predicate Device: - PediFlex™ Flexible Nail System (K201838, OrthoPediatrics Corp.) IV. Device Description The PediFlex™ Flexible Nail System includes stainless steel and titanium f… | 2021 |
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 29 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow, or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251362: PediFlex™ Flexible Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251362
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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