# K190963: DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jul 23, 2019 after 102 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). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093772: Synthes Sternal Fixation System, Synthes (2010) Summary page 6.
- K112689: Synthes Sternal Fixation System, Synthes, Inc. (2011) Summary page 6.
- K161590: MatrixRIB Fixation System, Synthes (USA) Products, LLC (2016) Summary page 8.
- K190409: MatrixRIB Fixation System, DePuy Synthes (2019). Cleared while this submission was under review Summary page 8.

## Indications for use
The DePuy Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. The DePuy Synthes Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. Contraindication: The DePuy Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients. 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. Contraindications: The MatrixRIB Fixation System is contraindicated for: • The fixation of the sternum in acute cardiac patients, due to the potential delay if emergent re-entry is required • Screw attachment or fixation to the clavicle or spine • Use in patients with latent or active infection, with sepsis, or who are unwilling or incapable of following postoperative care instructions.

Source page: https://510kreport.com/device/K190963
Methodology: https://510kreport.com/methodology