# K190409: MatrixRIB Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: May 3, 2019 after 71 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: 15 generations back to K761228 (1976). 45 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162974: Biomet Microfixation RibFix Blu Thoracic Fixation System, Biomet Microfixation (2016) Summary page 4.

## Most influential descendants
- K252166: RIB LINK™ Fixation System (2026), 0 descendants of its own
- K233967: DePuy Synthes MatrixSTERNUM Fixation System (2024), 0 descendants of its own
- K190963: DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional (2019), 0 descendants of its own

## Indications for use
The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where: DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of: • Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects • Pectus Excavatum, Pectus Carinatum, and other chest wall deformities DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of: • Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects • Pectus Excavatum, Pectus Carinatum, and other chest wall deformities DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for fixation, stabilization and reconstruction of: • Sternum fractures, fusions, and/or osteotomies • Pectus Excavatum, Pectus Carinatum, and other chest wall deformities The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs.

Source page: https://510kreport.com/device/K190409
Methodology: https://510kreport.com/methodology