510(k) Report

510(k) · Cleared

Cleared

S.E.a.L. Fracture Fusion Tube

K140158510(k) TraditionalCleared May 29, 2014127-day reviewClass II21 CFR 888.3030

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

Dne, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on May 29, 2014 as substantially equivalent to K093550 (Small Bone Innovations, Inc., 2010) and 4 other predicates after a 127-day review. Its family tree reaches back 3 generations to 1983.

Decided
May 29, 2014
Review
127 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K831576 (1983). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2005: 2 other ancestors1997: 1 other ancestor1995: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1988: 1 other ancestor1986: 1 other ancestorK831576 · Orthofix · Electro-Biology, Inc. · 1983K955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalledK052196 · Vilex X-Fix · Vilex, Inc. · 200519801985199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors K052196 · Vilex X-Fix · Vilex, Inc. · 2005K955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalledK831576 · Orthofix · Electro-Biology, Inc. · 19830
  1. Root · 3 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
  2. 2 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
  3. 1 generation backK052196 Vilex X-FixVilex, Inc. · 2005
  4. This deviceK140158 S.E.a.L. Fracture Fusion TubeDne, LLC · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K831576OrthofixElectro-Biology, Inc.1983—
−2K955848Orthofix ModulsystemOrthofix, Inc.199623
−1K052196Vilex X-FixVilex, Inc.2005—
0 (this device)K140158S.E.a.L. Fracture Fusion TubeDne, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198810
199410
199510
199610
199710
200520
201010
FIG. 1 — Lineage of K140158, 1983–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 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? (5)

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
*K093550Mini Rail External Fixator System
Summary page 1
…on: 21 CFR section 888.3030 Device panel: Orthopedic Legally Marketed SBi Mini Rail External Fixation System (Small Bone Innovations, Inc., K093550) Predicate Devices: Vilex Rail Fixation System (Vilex eX-Fix, K052196) DFS ®D MiniFix…
Small Bone Innovations, Inc.2010—
*K052196Vilex X-Fix
Summary page 1
…Legally Marketed SBi Mini Rail External Fixation System (Small Bone Innovations, Inc., K093550) Predicate Devices: Vilex Rail Fixation System (Vilex eX-Fix, K052196) DFS ®D MiniFixator (EBI (Biomet), K951357/K970290) Tomahawk Mi…
Vilex, Inc.2005—
*K951357Ebi Small External Fixator (S/E/F/)
Summary page 1
…tions, Inc., K093550) Predicate Devices: Vilex Rail Fixation System (Vilex eX-Fix, K052196) DFS ®D MiniFixator (EBI (Biomet), K951357/K970290) Tomahawk Mini Fixator (Wright Medical, K052005) Submitter: DNE, [[…
Electro-Biology, Inc.1995—
*K970290Ebi X Fix Dynafix Mini External Fixation System
Summary page 1
…nc., K093550) Predicate Devices: Vilex Rail Fixation System (Vilex eX-Fix, K052196) DFS ®D MiniFixator (EBI (Biomet), K951357/K970290) Tomahawk Mini Fixator (Wright Medical, K052005) Submitter: DNE, [[C…
Ebi, L.P.1997—
*K052005R&R External Fixation System
Summary page 1
…Fix, K052196) DFS ®D MiniFixator (EBI (Biomet), K951357/K970290) Tomahawk Mini Fixator (Wright Medical, K052005) Submitter: DNE, [[C 2225 Park Place Slating…
R&R Medical, Inc.2005—

Also cleared against K093550: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 31 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K093550.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

Indications for use as stated in the FDA summary.

Also cleared against K093550

2 other devices cite the same predicate.

  • K172438ARBOR External Fixation SystemGlobus Medical, Inc. · 2018
  • K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014

More from Dne, LLC

3 FDA decisions under this applicant name. See the company

  • K151580D.N.E. External Fixation SystemDne, LLC · 20161 recall
  • K113106Dne External Fixation SystemDne, LLC · 2012

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K140158 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140158: S.E.a.L. Fracture Fusion Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140158

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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