510(k) Report

510(k) · Cleared

Cleared

Orthopediatrics Pediflex Flexible Nail System

K082375510(k) TraditionalCleared Oct 17, 200860-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

OrthoPediatrics Corp. · HTY Pin, Fixation, Smooth

Cleared on Oct 17, 2008 as substantially equivalent to K081097 (Orthopediatrics, LLC, 2008) and 7 other predicates after a 60-day review. Its family tree reaches back 4 generations to 1996. 10 later devices descend from it.

Decided
Oct 17, 2008
Review
60 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
8

Its longest line of descent runs back 4 generations to K960642 (1996). 9 ancestors in all. 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor2015: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2025: 4 descendants cleared2023: 1 descendant cleared2026: 1 descendant clearedK960642 · Nancy Nail · Landos, Inc. · 1996K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 1997K032687 · Ace Nancy Nail · DePuy Orthopaedics, Inc. · 2003K081097 · Orthopediatrics Pediflex Flexible Nail System · Orthopediatrics, LLC · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K081097 · Orthopediatrics Pediflex Flexible Nail System · Orthopediatrics, LLC · 2008K032687 · Ace Nancy Nail · DePuy Orthopaedics, Inc. · 2003K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 1997K960642 · Nancy Nail · Landos, Inc. · 19960+5
  1. Root · 4 generations backK960642 Nancy NailLandos, Inc. · 1996
  2. 3 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
  3. 2 generations backK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
  4. 1 generation backK081097 Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC · 2008
  5. This deviceK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
  6. Descendant · cites it directly · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled
  7. Descendant · 2 generations on · 5 of its ownK192710 The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020
  8. Descendant · 3 generations on · 2 of its ownK231266 Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023
  9. Descendant · 4 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
  10. Descendant · cites it directly · 1 of its ownK201838 PediFlex Flexible Nail SystemOrthoPediatrics Corp. · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2015: 12017: 12020: 12021: 12023: 12025: 42026: 1
2015high 4 (2025) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all
  • K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · cites it directly6descendants
  • K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020 · 2 generations on5descendants
  • K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023 · 3 generations on2descendants
  • K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 4 generations on1descendant
  • K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp. · 2021 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K960642Nancy NailLandos, Inc.1996—
−3K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa)1997—
−2K032687Ace Nancy NailDePuy Orthopaedics, Inc.2003—
−1K081097Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC2008—
0 (this device)K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.2008—
+1K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.20151
+2K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.2020—
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.2023—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.2025—
+1K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200410
200510
200610
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
202010
202110
202310
202540
202610
FIG. 1 — Lineage of K082375, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K081097Orthopediatrics Pediflex Flexible Nail System
Summary page 1
…bone fastener: Class II per 21 CFR §888.3040 DEVICE PRODUCT CODE(S): HTY SUBSTANTIALLY EQUIVALENT DEVICES: Pedi-Flex Nail (K081097), OrthoPediatrics, Corp. Synthes EIN (K971783, K042135, K053105), Synthes (USA) Nancy Nail (K…
Orthopediatrics, LLC2008—
*K971783Synthes Elastic Intramedullary Nail (Ein) System
Summary page 1
…ICE PRODUCT CODE(S): HTY SUBSTANTIALLY EQUIVALENT DEVICES: Pedi-Flex Nail (K081097), OrthoPediatrics, Corp. Synthes EIN (K971783, K042135, K053105), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. Pediatric Fixation Ro…
Synthes (Usa)1997—
*K042135Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)
Summary page 1
…CT CODE(S): HTY SUBSTANTIALLY EQUIVALENT DEVICES: Pedi-Flex Nail (K081097), OrthoPediatrics, Corp. Synthes EIN (K971783, K042135, K053105), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. Pediatric Fixation Rods (K0007…
Synthes (Usa)2004—
*K053105Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap
Summary page 1
…): HTY SUBSTANTIALLY EQUIVALENT DEVICES: Pedi-Flex Nail (K081097), OrthoPediatrics, Corp. Synthes EIN (K971783, K042135, K053105), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. Pediatric Fixation Rods (K000764), Biom…
Synthes (Usa)2005—
*K032687Ace Nancy Nail
Summary page 1
…Pedi-Flex Nail (K081097), OrthoPediatrics, Corp. Synthes EIN (K971783, K042135, K053105), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. Pediatric Fixation Rods (K000764), Biomet, Inc. Synthes EIN (K081452), Synt…
DePuy Orthopaedics, Inc.2003—
*K000764Pediatric Fixation Rods
Summary page 1
…Synthes EIN (K971783, K042135, K053105), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. Pediatric Fixation Rods (K000764), Biomet, Inc. Synthes EIN (K081452), Synthes (USA) Metaizeau Nailing System (K063225), Howme…
Biomet, Inc.2000—
*K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System
Summary page 1
…), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. Pediatric Fixation Rods (K000764), Biomet, Inc. Synthes EIN (K081452), Synthes (USA) Metaizeau Nailing System (K063225), Howmedica DEVICE DESCRIPTION: Line extension includes 1.…
Synthes (Usa)2008—
*K063225Metaizeau Nailing System
Summary page 1
…Inc. Pediatric Fixation Rods (K000764), Biomet, Inc. Synthes EIN (K081452), Synthes (USA) Metaizeau Nailing System (K063225), Howmedica DEVICE DESCRIPTION: Line extension includes 1.5 and 4.5 mm diameters in 300mm and 450 mm lengths, respectively, wh…
Howmedica Osteonics Corp.20061

Also cleared against K081097: 1 other device →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.20156
K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp.20211
K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILOrthofix Srl20170

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 5 companies; a new generation was cleared every 4.7 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K143355 (Pega Medical, Inc., 2015) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K081097.

How does its category compare?

All HTY devices

HTY 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

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

What is it indicated for?

The PediFlexTM 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.

Also cleared against K081097

1 other device cites the same predicate.

  • K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp. · 2021

More from OrthoPediatrics Corp.

41 FDA decisions under this applicant name. See the company

  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp. · 2026
  • K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp. · 2025
  • K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp. · 2025
  • K243963Pediatric Plating Platform HipOrthoPediatrics Corp. · 2025

Recent decisions in HTY

The HTY category page

  • K262126Cerclage Wires;K-wires;Steinmann PinsMK Medical GmbH · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions · 2025
  • K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
  • K250315Ronavis – FX (FX-001)AIRS, Inc. · 2025

https://510kreport.com/device/K082375 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082375: 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/K082375

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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