# K133785: Tritium Sternal Cable Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Jan 27, 2014 after 46 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K761228 (1976). 27 ancestors in all.
45 later devices descend from it; 2 cite 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)
- K122293: Pioneer Sternal Cable Plate System, Pioneer Surgical Technology, Inc. (2012) Summary page 1.
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 1.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own

## Recalls of this device
- Jun 11, 2014 · Class II · Z-2076-2014: Lack of Sterility Assurance

## 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/K133785
Methodology: https://510kreport.com/methodology