510(k) Report

510(k) · Cleared

Cleared

Synthes Elastic Intramedullary Nail (Ein) System

K971783510(k) TraditionalCleared Jul 18, 199765-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

Synthes (Usa) · HTY Pin, Fixation, Smooth

Cleared on Jul 18, 1997 as substantially equivalent to K960642 (Landos, Inc., 1996) after a 65-day review. Its family tree reaches back 1 generation to 1996. 49 later devices descend from it.

Decided
Jul 18, 1997
Review
65 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K960642 (1996). 49 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2017: 5 descendants cleared2024: 5 descendants cleared2015: 2 descendants cleared2003: 2 descendants cleared2008: 4 descendants cleared2004: 2 descendants cleared2022: 3 descendants cleared2018: 1 descendant cleared2025: 6 descendants cleared2016: 2 descendants cleared2021: 5 descendants cleared2012: 1 descendant cleared2020: 5 descendants cleared2026: 5 descendants cleared2023: 1 descendant clearedK960642 · Nancy Nail · Landos, Inc. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 13 descendants2 generations forward: 18 descendants3 generations forward: 9 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants K960642 · Nancy Nail · Landos, Inc. · 19960+5
  1. Root · 1 generation backK960642 Nancy NailLandos, Inc. · 1996
  2. This deviceK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
  3. Descendant · cites it directly · 29 of its ownK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
  4. Descendant · cites it directly · 17 of its ownK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
  5. Descendant · cites it directly · 15 of its ownK020885 Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · Recalled
  6. Descendant · 2 generations on · 14 of its ownK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
  7. Descendant · 2 generations on · 14 of its ownK041393 Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2003: 22004: 22008: 42012: 12015: 22016: 22017: 52018: 12020: 52021: 52022: 32023: 12024: 52025: 62026: 5
2003high 6 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 49 · See all
  • K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008 · cites it directly29descendants
  • K032687Ace Nancy NailDePuy Orthopaedics, Inc. · 2003 · cites it directly17descendants
  • K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · cites it directly15descendants
  • K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa) · 2008 · 2 generations on14descendants
  • K041393Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960642Nancy NailLandos, Inc.1996—
0 (this device)K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa)1997—
+1K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)2008—
+1K032687Ace Nancy NailDePuy Orthopaedics, Inc.2003—
+1K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc.20034
+2K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)2008—
+2K041393Fassier-Duval Telscopic IM SystemPega Medical, Inc.20045

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200420
200840
201210
201520
201620
201750
201810
202050
202150
202230
202310
202450
202560
202650
FIG. 1 — Lineage of K971783, 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? (1)

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
*K960642Nancy Nail
Summary page 1
…ssell Road JUL |8 997 Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri Intramedullary fixation rod/pin Class II, 21 CFR 888.3020; 888.3040 Landos Nancy Nail (K960642) Synthes EIN is a flexible intramedullary fixation device. The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, ea…
Landos, Inc.1996—

What descends from it? (49)

See all 49

13 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
K032687Ace Nancy NailDePuy Orthopaedics, Inc.200317
K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc.200315
K081097Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC200811
K143276Acumed Small Bone IM Nail SystemAcumed, LLC201510
K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.200810
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182
K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC20171
K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171
K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd.20240

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?

  • Its one ancestor has no recall.
  • Of its descendants, K081452 (Synthes (Usa), 2008) has gone furthest, with 29 descendants of its own.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary 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-statured patients. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 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/K971783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971783: Synthes Elastic Intramedullary Nail (Ein) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971783

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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