# K120016: Pioneer Sternal Assist Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Jul 26, 2012 after 205 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: 3 generations back to K011076 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101170: Acute Innovations Sternal Fixation System, Acute Innovations, LLC (2010)
- K110789: Synthes Sternal Zipfix System, Synthes (Usa) (2011)
- K935481: Sponger Cable System, Modification, Pioneer Surgical Technology (1994) Summary page 1.
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 1.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.

## Indications for use
The Pioneer Sternal Assist Implant 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/K120016
Methodology: https://510kreport.com/methodology