# K130431: Compressyn Band

- Pathway: 510(k) (Traditional)
- Applicant: Dallen Medical, Inc.
- Decided: Jul 25, 2013 after 154 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K761228 (1976). 85 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101484: Compressyn Band, Dallen Medical (2011) Summary page 1.

## Most influential descendants
- K133858: Tensyn Band (2014), 3 descendants of its own
- 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
The Compressyn Tm Band is intended for use in stabilization and fixation of anterior chest wail fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Source page: https://510kreport.com/device/K130431
Methodology: https://510kreport.com/methodology