# K233967: DePuy Synthes MatrixSTERNUM Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes GmbH
- Decided: May 9, 2024 after 146 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). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161896: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2016) Summary page 4.
- K161590: MatrixRIB Fixation System, Synthes (USA) Products, LLC (2016) Summary page 4.
- K190409: MatrixRIB Fixation System, DePuy Synthes (2019) Summary page 4.

## Indications for use
The DePuy Synthes MatrixSTERNUM Fixation System is indicated for use in adults with normal bone quality. MatrixSTERNUM Sternal Body Plates are indicated for internal fixation of bone discontinuities following sternotomy. MatrixSTERNUM Thoracotomy Plates are indicated for internal fixation of bone and/or cartilage discontinuities following thoracotomy.

Source page: https://510kreport.com/device/K233967
Methodology: https://510kreport.com/methodology