510(k) · Cleared
ClearedMatrixRIB Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone
Cleared on Nov 3, 2016 as substantially equivalent to K133616 (Synthes (USA) Products, LLC, 2014) after a 147-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it.
- Decided
- Nov 3, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972420 (1997). 14 ancestors in all, the oldest K942340 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
- 4 generations backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
- 3 generations backK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
- 2 generations backK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
- 1 generation backK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
- This deviceK161590 MatrixRIB Fixation SystemSynthes (USA) Products, LLC · 2016
- Descendant · cites it directly · 0 of its ownK232829 Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda. · 2024
- Descendant · cites it directly · 0 of its ownK233967 DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH · 2024
- Descendant · cites it directly · 0 of its ownK190963 DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · cites it directly0descendants
- K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH · 2024 · cites it directly0descendants
- K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972420 | Lorenz Pectus Support Bar | Walter Lorenz Surgical, Inc. | 1997 | — |
| −4 | K981789 | Lorenz Pectus Support Bar Stabilizer | Walter Lorenz Surgical, Inc. | 1998 | — |
| −3 | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer… | Walter Lorenz Surgical, Inc. | 2006 | — |
| −2 | K073556 | Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos | Medxpert GmbH | 2008 | — |
| −1 | K133616 | Matrixrib Fixation System | Synthes (USA) Products, LLC | 2014 | — |
| 0 (this device) | K161590 | MatrixRIB Fixation System | Synthes (USA) Products, LLC | 2016 | — |
| +1 | K232829 | Versalock Rib and Sternum Plates System | GM Dos Reis Industria e Comercio Ltda. | 2024 | — |
| +1 | K233967 | DePuy Synthes MatrixSTERNUM Fixation System | Synthes GmbH | 2024 | — |
| +1 | K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133616 | Matrixrib Fixation SystemSummary page 5…xation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code: HRS 5.3. Predicate Devices Primary Predicate: Synthes MatrixRIB Fixation System (K133616) Reference Devices: Synthes MatrixRIB Fixation System (K081623) Synthes Sternal Fixation System (K112689, K093772, K081700, K0500… | 2014 |
| † | K081623 | Synthes Rib Fixation System | 2008 |
| † | K112689 | Synthes Sternal Fixation System | 2011 |
| † | K093772 | Synthes Sternal Fixation System | 2010 |
| † | K081700 | Synthes (Usa) Sternal Fixation System - Line Extension | 2008 |
| † | K050041 | Synthes (Usa) Sterile Sternal Fixation System | 2005 |
| † | K010943 | Synthes Sternal Fixation System | 2001 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K232829 (GM Dos Reis Industria e Comercio Ltda., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133616.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
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…
Read the full statement (149 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161590: MatrixRIB Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161590
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026