# K181607: Thorecon Rigid Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: A & E Medical Corporation
- Decided: Oct 12, 2018 after 115 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K761228 (1976). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173579: Thorecon™ Fixation System, A & E Medical Corporation (2018) Summary page 4.

## Recalls of this device
- Sep 10, 2019 · Class II · Z-0243-2020: Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- Sep 10, 2019 · Class II · Z-0244-2020: Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- Sep 10, 2019 · Class II · Z-0242-2020: Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- Sep 10, 2019 · Class II · Z-0245-2020: Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
- Sep 10, 2019 · Class II · Z-0246-2020: Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.

## Indications for use
The Thorecon Rigid 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/K181607
Methodology: https://510kreport.com/methodology