510(k) · Cleared
ClearedDePuy Synthes MatrixSTERNUM Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes GmbH · HRS Plate, Fixation, Bone
Cleared on May 9, 2024 as substantially equivalent to K161896 (Biomet Microfixation, 2016) and 2 other predicates after a 146-day review. Its family tree reaches back 16 generations to 1976.
- Decided
- May 9, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K761228 (1976). 48 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 12 generations between
- 3 generations backK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 2 generations backK162974 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 1 generation backK190409 MatrixRIB Fixation SystemDePuy Synthes · 2019
- This deviceK233967 DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH · 2024
Show all 16 generations
- Root · 16 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 15 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 14 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 13 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 12 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 11 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 10 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 9 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 8 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 7 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 6 generations backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- 5 generations backK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
- 4 generations backK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
- 3 generations backK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 2 generations backK162974 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- 1 generation backK190409 MatrixRIB Fixation SystemDePuy Synthes · 2019
- This deviceK233967 DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −15 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −14 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −13 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −12 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −11 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −10 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −9 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −8 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −7 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| −6 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| −5 | K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| −4 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| −3 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| −2 | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| −1 | K190409 | MatrixRIB Fixation System | DePuy Synthes | 2019 | — |
| 0 (this device) | K233967 | DePuy Synthes MatrixSTERNUM Fixation System | Synthes GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K161896 | Biomet Microfixation Sternal Closure SystemSummary page 4…and MatrixSTERNUM Screws: Biomet Microfixation Sternal Closure System (SternaLock Blu Primary Closure Predicate / System), K161896 Reference Predicate for MatrixSTERNUM Thoracotomy Plates and MatrixSTERNUM devices Screws:… | 2016 |
| * | K161590 | MatrixRIB Fixation SystemSummary page 4…eference Predicate for MatrixSTERNUM Thoracotomy Plates and MatrixSTERNUM devices Screws: DePuy Synthes MatrixRIB Fixation System, K161590 / K190409 Reference Device for MatrixSTERNUM Sternal Body Plates: Ethicon Cerclage Wire (K9… | 2016 |
| * | K190409 | MatrixRIB Fixation SystemSummary page 4…Predicate for MatrixSTERNUM Thoracotomy Plates and MatrixSTERNUM devices Screws: DePuy Synthes MatrixRIB Fixation System, K161590 / K190409 Reference Device for MatrixSTERNUM Sternal Body Plates: Ethicon Cerclage Wire (K946173)… | 2019 |
| † | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 48 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 48 ancestors have a recall of any class.
- 3 other devices also cite its predicate K161896.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233967: DePuy Synthes MatrixSTERNUM Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233967
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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