# K261054: RibPlate System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Jul 1, 2026 after 92 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: 16 generations back to K761228 (1976). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212608: RibFix Blu Thoracic Fixation System, Biomet Microfixation (2022) Summary page 6.

## Indications for use
The RibPlate System is intended for use in the stabilization and fixation of fractures and reconstructions in the chest wall, including sternal reconstructive surgical procedures to promote bony fusion. The RibPlate system can be used in normal and poor bone.

Source page: https://510kreport.com/device/K261054
Methodology: https://510kreport.com/methodology