# K252661: SternaFuse Ti Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Innovations, LLC
- Decided: Nov 19, 2025 after 89 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: 11 generations back to K761228 (1976). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202914: SternaFuse Fixation System, Fusion Innovations, LLC (2022). Our reading of the summary gave K202904, FDA’s number for Surgical Face Mask (Jiangxi Feilikang Medical Technology Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SternaFuse Fixation System”.
- K111908: Biomet Microfixation Sternal Closure System, Biomet Microfixation, Inc. (2011)

## Indications for use
The SternaFuse Ti Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall or sternum, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures to promote fusion . The system is intended for use in patients with normal and/or poor bone quality. The device is for prescription use only.

Source page: https://510kreport.com/device/K252661
Methodology: https://510kreport.com/methodology