510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System

K081452510(k) TraditionalCleared Jul 18, 200856-day reviewClass II21 CFR 888.3020

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

Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jul 18, 2008 as substantially equivalent to K042135 (Synthes (Usa), 2004) and 3 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1996. 29 later devices descend from it.

Decided
Jul 18, 2008
Review
56 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K960642 (1996). 5 ancestors in all. 29 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2015: 2 descendants cleared2016: 1 descendant cleared2008: 2 descendants cleared2017: 5 descendants cleared2020: 4 descendants cleared2021: 3 descendants cleared2025: 5 descendants cleared2022: 2 descendants cleared2023: 1 descendant cleared2024: 2 descendants cleared2026: 2 descendants clearedK960642 · Nancy Nail · Landos, Inc. · 1996K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 6 descendants3 generations forward: 9 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 1997K960642 · Nancy Nail · Landos, Inc. · 19960+5
  1. Root · 2 generations backK960642 Nancy NailLandos, Inc. · 1996
  2. 1 generation backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
  3. This deviceK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
  4. Descendant · cites it directly · 14 of its ownK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
  5. Descendant · 2 generations on · 10 of its ownK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
  6. Descendant · cites it directly · 10 of its ownK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
  7. Descendant · cites it directly · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled
  8. Descendant · 2 generations on · 5 of its ownK192710 The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2008: 22015: 22016: 12017: 52020: 42021: 32022: 22023: 12024: 22025: 52026: 2
2008high 5 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 29 · See all
  • K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa) · 2008 · cites it directly14descendants
  • K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015 · 2 generations on10descendants
  • K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008 · cites it directly10descendants
  • K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · cites it directly6descendants
  • K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K960642Nancy NailLandos, Inc.1996—
−1K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa)1997—
0 (this device)K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)2008—
+1K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)2008—
+2K143276Acumed Small Bone IM Nail SystemAcumed, LLC2015—
+1K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.2008—
+1K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.20151
+2K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201520
201610
201750
202040
202130
202220
202310
202420
202550
202620
FIG. 1 — Lineage of K081452, 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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (4)

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
*K042135Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)
Summary page 1
…Intramedullary Nail System Classification: 21 CFR 888.3020: Intramedullary fixation rod Predicate Devices: Synthes Elastic Intramedullary Nail (EIiN) System (K042135 & K9717 83) Metaizeau Nailing System (K063225) Synthes Elastic…
Synthes (Usa)2004—
*K971783Synthes Elastic Intramedullary Nail (Ein) System
Summary page 1
…ssification: 21 CFR 888.3020: Intramedullary fixation rod Predicate Devices: Synthes Elastic Intramedullary Nail (EIiN) System (K042135 & K9717 83) Metaizeau Nailing System (K063225) Synthes Elastic Intramnedullary Nail (EIN) End Ca…
Synthes (Usa)1997—
*K063225Metaizeau Nailing System
Summary page 1
…n rod Predicate Devices: Synthes Elastic Intramedullary Nail (EIiN) System (K042135 & K9717 83) Metaizeau Nailing System (K063225) Synthes Elastic Intramnedullary Nail (EIN) End Cap (K053 105) Device Description: The Synthes Stainless…
Howmedica Osteonics Corp.20061
*K053105Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap
Summary page 1
…2135 & K9717 83) Metaizeau Nailing System (K063225) Synthes Elastic Intramnedullary Nail (EIN) End Cap (K053 105) Device Description: The Synthes Stainless Steel Elastic Intramedullary Nail System consists of intramed…
Synthes (Usa)2005—

Also cleared against K042135: 8 other devices →

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)200814
K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.200810
K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.20156
K201961IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc.20202
K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC20171
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170
K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160

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 2 companies; a new generation was cleared every 11.0 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K082148 (Synthes (Usa), 2008) has gone furthest, with 14 descendants of its own.
  • 8 other devices also cite its predicate K042135.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

Indications for use as stated in the FDA summary.

Also cleared against K042135

8 other devices cite the same predicate.

  • K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2022
  • K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
  • K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
  • K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017
  • K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K081452 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081452

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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