510(k) · Cleared
ClearedDePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
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 Jul 23, 2019 as substantially equivalent to K093772 (Synthes, 2010) and 3 other predicates after a 102-day review. Its family tree reaches back 16 generations to 1976.
- Decided
- Jul 23, 2019
- Review
- 102 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K761228 (1976). 47 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 deviceK190963 DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC · 2019
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 deviceK190963 DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC · 2019
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) | 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 |
|---|---|---|
| 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 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K093772 | Synthes Sternal Fixation SystemSummary page 6…Classification Name(s): Plate, Fixation, Bone; Screw, Fixation, Bone Regulatory Class: Class II, §888.3030; §888.3040 Product Code(s): HRS; HWC 1.3. Predicate Device K093772, K112689 DePuy Synthes Sternal Fixation System 1.4. Device Description The DePuy Synthes Sternal Fixation System consists of ma… | 2010 |
| * | K112689 | Synthes Sternal Fixation SystemSummary page 6…ation Name(s): Plate, Fixation, Bone; Screw, Fixation, Bone Regulatory Class: Class II, §888.3030; §888.3040 Product Code(s): HRS; HWC 1.3. Predicate Device K093772, K112689 DePuy Synthes Sternal Fixation System 1.4. Device Description The DePuy Synthes Sternal Fixation System consists of machined ti… | 2011 |
| * | K161590 | MatrixRIB Fixation SystemSummary page 8…xRIB Fixation System - MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II, §888.3030 Product Code(s): HRS 1.3. Predicate Device K161590, K190409 DePuy Synthes MatrixRIB Fixation System 1.4. Device Description The proposed additions to the MatrixRlB Fixation Syste… | 2016 |
| * | K190409 | MatrixRIB Fixation System Cleared while this submission was under review Summary page 8…tion System - MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II, §888.3030 Product Code(s): HRS 1.3. Predicate Device K161590, K190409 DePuy Synthes MatrixRIB Fixation System 1.4. Device Description The proposed additions to the MatrixRlB Fixation System include… | 2019 |
| † | K133616 | Matrixrib Fixation System | 2014 |
| † | K081623 | Synthes Rib Fixation System | 2008 |
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 43 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 5 of the 47 ancestors have a recall of any class.
- 5 other devices also cite its predicate K093772.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 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.…
Read the full statement (299 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190963: DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190963
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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