# K122293: Pioneer Sternal Cable Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Oct 12, 2012 after 73 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 9 generations back to K761228 (1976). 26 ancestors in all.
46 later devices descend from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- K935481: Sponger Cable System, Modification, Pioneer Surgical Technology (1994) Summary page 1.
- K011076: Lorenz Sternal Closure System with Modular Screw, Walter Lorenz Surgical, Inc. (2001)
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System, Biomet Microfixation, Inc. (2011)
- K031508: Synthes (Usa) Sternal Reconstruction System, Synthes (Usa) (2003) Summary page 1.
- K033816: Synthes (Usa) Modification to Sternal Reconstruction System, Synthes (Usa) (2004) Summary page 1.

## Most influential descendants
- K133785: Tritium Sternal Cable Plate System (2014), 45 descendants of its own
- K150581: Tritium Sternal Cable Plate System (2015), 44 descendants of its own
- K161876: Tritium® Sternal Cable Plate System (2016), 43 descendants of its own
- K193468: Tritium Sternal Cable Plate System (2020), 40 descendants of its own
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System (2021), 39 descendants of its own

## Indications for use
The Pioneer Sternal Cable Plate 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.

Source page: https://510kreport.com/device/K122293
Methodology: https://510kreport.com/methodology