510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)

K042135510(k) TraditionalCleared Oct 7, 200459-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 Oct 7, 2004 after a 59-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.

Decided
Oct 7, 2004
Review
59 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

36 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2015: 3 descendants cleared2008: 3 descendants cleared2007: 1 descendant cleared2022: 2 descendants cleared2017: 5 descendants cleared2018: 1 descendant cleared2016: 2 descendants cleared2020: 4 descendants cleared2021: 3 descendants cleared2026: 3 descendants cleared2025: 5 descendants cleared2023: 1 descendant cleared2024: 2 descendants cleared200020052010201520202025
  1. This deviceK042135 Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line…Synthes (Usa) · 2004
  2. Descendant · cites it directly · 29 of its ownK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
  3. Descendant · 2 generations on · 14 of its ownK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
  4. Descendant · 3 generations on · 10 of its ownK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
  5. Descendant · cites it directly · 10 of its ownK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
  6. Descendant · 2 generations on · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32014: 12015: 32016: 22017: 52018: 12020: 42021: 32022: 22023: 12024: 22025: 52026: 3
2007high 5 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 36 · See all
  • K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008 · cites it directly29descendants
  • K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa) · 2008 · 2 generations on14descendants
  • K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015 · 3 generations on10descendants
  • K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008 · cites it directly10descendants
  • K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042135Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)Synthes (Usa)2004—
+1K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)2008—
+2K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)2008—
+3K143276Acumed Small Bone IM Nail SystemAcumed, LLC2015—
+1K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.2008—
+2K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.20151

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
201410
201530
201620
201750
201810
202040
202130
202220
202310
202420
202550
202630
FIG. 1 — Lineage of K042135, 2004–2026Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Synthes Elastic Intramedullary Nail (FIN) System
Named without a submission number
—
*—Depuy Ace Nancy Nail
Named without a submission number
—

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)200829
K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.200810
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182
K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC20171
K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151
K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170
K131984Synthes Synsonic Ulna NailSynthes (Usa)20140
K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.20070

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?

  • Of its descendants, K081452 (Synthes (Usa), 2008) has gone furthest, with 29 descendants of its own.

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.

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 epiphyscal 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 tf point which avoids disruption to the bone growth plate.

Indications for use as stated in the FDA summary.

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/K042135 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042135

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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