# K173579: Thorecon™ Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: A & E Medical Corporation
- Decided: Feb 12, 2018 after 84 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: 13 generations back to K761228 (1976). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161876: Tritium® Sternal Cable Plate System, Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (2016) Summary page 4.
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 4.
- K151019: SternaLock® 360 Sternal Closure System, Biomet Microfixation (2015) Summary page 4.
- K150581: Tritium Sternal Cable Plate System, Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (2015) Summary page 4.
- K111908: Biomet Microfixation Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 4.

## Most influential descendants
- K181607: Thorecon Rigid Fixation System (2018), 0 descendants of its own

## Indications for use
The Thorecon Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.

Source page: https://510kreport.com/device/K173579
Methodology: https://510kreport.com/methodology