510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension

K082148510(k) TraditionalCleared Aug 11, 200812-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 Aug 11, 2008 as substantially equivalent to K081452 (Synthes (Usa), 2008) and 1 other predicate after a 12-day review. Its family tree reaches back 3 generations to 1996. 14 later devices descend from it.

Decided
Aug 11, 2008
Review
12 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K960642 (1996). 6 ancestors in all. 14 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2006: 1 other ancestor2004: 1 other ancestor2015: 1 descendant cleared2017: 4 descendants cleared2016: 1 descendant cleared2025: 1 descendant cleared2022: 2 descendants cleared2020: 1 descendant cleared2024: 1 descendant cleared2021: 2 descendants cleared2026: 1 descendant clearedK960642 · Nancy Nail · Landos, Inc. · 1996K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 1997K081452 · Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System · Synthes (Usa) · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K081452 · Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System · Synthes (Usa) · 2008K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 1997K960642 · Nancy Nail · Landos, Inc. · 19960+5
  1. Root · 3 generations backK960642 Nancy NailLandos, Inc. · 1996
  2. 2 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
  3. 1 generation backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
  4. This deviceK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
  5. Descendant · cites it directly · 10 of its ownK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
  6. Descendant · 2 generations on · 4 of its ownK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
  7. Descendant · 3 generations on · 3 of its ownK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
  8. Descendant · 4 generations on · 1 of its ownK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
  9. Descendant · cites it directly · 1 of its ownK163488 Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 42020: 12021: 22022: 22024: 12025: 12026: 1
2015high 4 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 14 · See all
  • K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015 · cites it directly10descendants
  • K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017 · 2 generations on4descendants
  • K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · 3 generations on3descendants
  • K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021 · 4 generations on1descendant
  • K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960642Nancy NailLandos, Inc.1996—
−2K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa)1997—
−1K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)2008—
0 (this device)K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)2008—
+1K143276Acumed Small Bone IM Nail SystemAcumed, LLC2015—
+2K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC2017—
+3K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC20212
+4K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower2021—
+1K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201740
202010
202120
202220
202410
202510
202610
FIG. 1 — Lineage of K082148, 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
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
*K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System
Summary page 1
…888.3020: Intramedullary fixation rod (H-SB) Predicate Devices: Synthes Stainless Steel Elastic Intrarnedullary Nail (E]N) System (K081452) Synthes Elastic Intramedullary Nail (EIN) End Cap (1(053105) Device Description: The Synthe…
Synthes (Usa)2008—
*K053105Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap
Summary page 1
…ss Steel Elastic Intrarnedullary Nail (E]N) System (K081452) Synthes Elastic Intramedullary Nail (EIN) End Cap (1(053105) Device Description: The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the…
Synthes (Usa)2005—

Also cleared against K081452: 6 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K143276Acumed Small Bone IM Nail SystemAcumed, LLC201510
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

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 1.2 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K143276 (Acumed, LLC, 2015) has gone furthest, with 10 descendants of its own.
  • 6 other devices also cite its predicate K081452.

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 K081452

6 other devices cite the same predicate.

  • K201961IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
  • 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
  • K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC · 2016
  • K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 20151 recall
  • K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008

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/K082148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082148

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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