# K161590: MatrixRIB Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Nov 3, 2016 after 147 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: 5 generations back to K972420 (1997). 14 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133616: Matrixrib Fixation System, Synthes (USA) Products, LLC (2014) Summary page 5.

## Most influential descendants
- K232829: Versalock Rib and Sternum Plates System (2024), 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 the 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/K161590
Methodology: https://510kreport.com/methodology