# K183172: Stryker SternalPlate System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Mar 5, 2019 after 109 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.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121302: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2012) Summary page 4.

## Most influential descendants
- K243491: SternalPlate Expansion (2024), 0 descendants of its own

## Indications for use
The SternalPlate system is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion.

Source page: https://510kreport.com/device/K183172
Methodology: https://510kreport.com/methodology