510(k) · Cleared
ClearedSynthes Sternal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes · HRS Plate, Fixation, Bone
Cleared on Mar 29, 2010 after a 111-day review. The FDA summary names its predicate without a number. 94 later devices descend from it.
- Decided
- Mar 29, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 6 citing it directly.
- This deviceK093772 Synthes Sternal Fixation SystemSynthes · 2010
- Descendant · cites it directly · 85 of its ownK110789 Synthes Sternal Zipfix SystemSynthes (Usa) · 2011 · Recalled
- Descendant · cites it directly · 78 of its ownK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- Descendant · 2 generations on · 75 of its ownK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- Descendant · 2 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- Descendant · 3 generations on · 43 of its ownK151019 SternaLock® 360 Sternal Closure SystemBiomet Microfixation · 2015
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 2011 · cites it directly85descendants
- K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · cites it directly78descendants
- K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012 · 2 generations on75descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 2 generations on45descendants
- K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation · 2015 · 3 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093772 | Synthes Sternal Fixation System | Synthes | 2010 | — |
| +1 | K110789 | Synthes Sternal Zipfix System | Synthes (Usa) | 2011 | 3 |
| +1 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| +2 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| +2 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| +3 | K151019 | SternaLock® 360 Sternal Closure System | Biomet Microfixation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 16 | 0 |
| 2025 | 15 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | — | Synthes Sternal Fixation System Named without a submission number | |
| * | — | Synthes Sterile Sternal Fixation System Named without a submission number | |
| * | — | Ethicon Stainless Steel Suture Wire Named without a submission number |
What descends from it? (94)
See all 946 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110789 | Synthes Sternal Zipfix System | 2011 | 85 |
| K111908 | Biomet Microfixation Sternal Closure System | 2011 | 78 |
| K112689 | Synthes Sternal Fixation System | 2011 | 31 |
| K133616 | Matrixrib Fixation System | 2014 | 26 |
| K122860 | KLS Martin Recon Talon | 2012 | 10 |
| K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | 2019 | 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?
- Of its descendants, K110789 (Synthes (Usa), 2011) has gone furthest, with 85 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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 Synthes (USA) 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.
Contraindications
The Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093772: Synthes Sternal 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/K093772
Report an extraction error
Are you the manufacturer?
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