# K141264: Tensyn Band, Tensyn Fracture Plates

- Pathway: 510(k) (Traditional)
- Applicant: Dallen Medical, Inc.
- Decided: Aug 21, 2014 after 98 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: 13 generations back to K954385 (1996). 167 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133858: Tensyn Band, Dallen Medical, Inc. (2014) Summary page 4.
- K132733: Orthohelix Syndesmosis Fixation Devices, Orthohelix Surgical Designs, Inc. (2014) Summary page 4.

## Most influential descendants
- K143092: Tensyn Plug (2015), 1 descendant of its own
- K150359: Tensyn Plug (2015), 0 descendants of its own

## Indications for use
TensynTM 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. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the TensynTM Band is used in conjunction with, but not connected to, supplemental fixation.

Source page: https://510kreport.com/device/K141264
Methodology: https://510kreport.com/methodology