# K133858: Tensyn Band

- Pathway: 510(k) (Traditional)
- Applicant: Dallen Medical, Inc.
- Decided: Feb 28, 2014 after 71 days
- Product code: HTN (Washer, Bolt Nut)
- 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: 11 generations back to K761228 (1976). 123 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131850: Tensyn Band, Dallen Medical, Inc. (2013) Summary page 1.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 1.
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 1.
- K130431: Compressyn Band, Dallen Medical, Inc. (2013) Summary page 1.

## Most influential descendants
- K141264: Tensyn Band, Tensyn Fracture Plates (2014), 2 descendants of its own
- K143092: Tensyn Plug (2015), 1 descendant of its own
- K150359: Tensyn Plug (2015), 0 descendants of its own

## Indications for use
Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.

Source page: https://510kreport.com/device/K133858
Methodology: https://510kreport.com/methodology