# K202914: SternaFuse Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Innovations, LLC
- Decided: Jan 26, 2022 after 484 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: 10 generations back to K761228 (1976). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111908: Biomet Microfixation Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 4.

## Most influential descendants
- K252661: SternaFuse Ti Fixation System (2025), 0 descendants of its own

## Indications for use
The SternaFuse® Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures, to promote fusion. The device is for prescription use only.

Source page: https://510kreport.com/device/K202914
Methodology: https://510kreport.com/methodology