510(k) · Cleared
ClearedStryker SternalPlate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · HRS Plate, Fixation, Bone
Cleared on Mar 5, 2019 as substantially equivalent to K121302 (Biomet Microfixation, 2012) after a 109-day review. Its family tree reaches back 11 generations to 1976. 1 later device descends from it.
- Decided
- Mar 5, 2019
- Review
- 109 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K761228 (1976). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 7 generations between
- 3 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 2 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 1 generation backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- This deviceK183172 Stryker SternalPlate SystemStryker · 2019
- Descendant · cites it directly · 0 of its ownK243491 SternalPlate ExpansionStryker Leibinger GmbH & Co KG · 2024
Show all 11 generations
- Root · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 10 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 9 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 8 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 7 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 6 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 5 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 4 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 3 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 2 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 1 generation backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- This deviceK183172 Stryker SternalPlate SystemStryker · 2019
Most influential descendants
Showing 1 of 1 · See all- K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −10 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −9 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −8 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −7 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −6 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −5 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −4 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −3 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −2 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| −1 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| 0 (this device) | K183172 | Stryker SternalPlate System | Stryker | 2019 | — |
| +1 | K243491 | SternalPlate Expansion | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K121302 | Biomet Microfixation Sternal Closure SystemSummary page 4…Metallic Bone Fixation Appliances and Accessories 21 CFR § 888.3030 Class 11 HRS III. PREDICATE DEVICE [§807.92(a)(3)] Biomet Microfixation Sternal Closure System — K121302 This predicate has not been subject to a design-related recall. Traditional 510(k) Stryker SternalPlate System Page-1 === Pag… | 2012 |
| † | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | 2015 |
| † | K014263 | Newgen/Universal Mandibular System | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243491 | SternalPlate Expansion | 2024 | 0 |
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 7 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K243491 (Stryker Leibinger GmbH & Co KG, 2024) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K121302.
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 SternalPlate system is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion.
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/K183172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183172: Stryker SternalPlate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183172
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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