510(k) · Cleared
ClearedOrthopediatrics Pediflex Flexible Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopediatrics, LLC · HTY Pin, Fixation, Smooth
Cleared on Jun 3, 2008 as substantially equivalent to K971783 (Synthes (Usa), 1997) and 1 other predicate after a 47-day review. Its family tree reaches back 3 generations to 1996. 11 later devices descend from it.
- Decided
- Jun 3, 2008
- Review
- 47 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960642 (1996). 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK960642 Nancy NailLandos, Inc. · 1996
- 2 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 1 generation backK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
- This deviceK081097 Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC · 2008
- Descendant · cites it directly · 10 of its ownK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
- Descendant · 2 generations on · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 5 of its ownK192710 The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK231266 Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023
- Descendant · 5 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008 · cites it directly10descendants
- K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · 2 generations on6descendants
- K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020 · 3 generations on5descendants
- K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023 · 4 generations on2descendants
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −2 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −1 | K032687 | Ace Nancy Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K081097 | Orthopediatrics Pediflex Flexible Nail System | Orthopediatrics, LLC | 2008 | — |
| +1 | K082375 | Orthopediatrics Pediflex Flexible Nail System | OrthoPediatrics Corp. | 2008 | — |
| +2 | K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | 2015 | 1 |
| +3 | K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | 2020 | — |
| +4 | K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023 | — |
| +5 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 1…s II per 21 CFR §888.3040 DEVICE PRODUCT CODE(S): HTY SUBSTANTIALLY EQUIVALENT DEVICES: Synthes EIN (K971783), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. DEVICE DESCRIPTION:… | 1997 |
| * | K032687 | Ace Nancy NailSummary page 1…HTY SUBSTANTIALLY EQUIVALENT DEVICES: Synthes EIN (K971783), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. DEVICE DESCRIPTION: The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters,… | 2003 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082375 (OrthoPediatrics Corp., 2008) has gone furthest, with 10 descendants of its own.
- 12 other devices also cite its predicate K971783.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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/K081097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081097: Orthopediatrics Pediflex Flexible Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081097
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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