# K140158: S.E.a.L. Fracture Fusion Tube

- Pathway: 510(k) (Traditional)
- Applicant: Dne, LLC
- Decided: May 29, 2014 after 127 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K831576 (1983). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093550: Mini Rail External Fixator System, Small Bone Innovations, Inc. (2010) Summary page 1.
- K052196: Vilex X-Fix, Vilex, Inc. (2005) Summary page 1.
- K951357: Ebi Small External Fixator (S/E/F/), Electro-Biology, Inc. (1995) Summary page 1.
- K970290: Ebi X Fix Dynafix Mini External Fixation System, Ebi, L.P. (1997) Summary page 1.
- K052005: R&R External Fixation System, R&R Medical, Inc. (2005) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K140158
Methodology: https://510kreport.com/methodology