510(k) · Cleared
Recalled · Class II · 2015Synthes Sternal Zipfix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDQ Cerclage, Fixation
Cleared on Jul 28, 2011 as substantially equivalent to K931271 (ETHICON, Inc., 1994) and 2 other predicates after a 128-day review. Its family tree reaches back 1 generation to 1994. 85 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 28, 2011
- Review
- 128 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931271 (1994). 3 ancestors in all. 85 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- This deviceK110789 Synthes Sternal Zipfix SystemSynthes (Usa) · 2011
- 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 · cites it directly · 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
- Descendant · 4 generations on · 40 of its ownK163007 Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation · 2016
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- 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 · cites it directly45descendants
- K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation · 2015 · 3 generations on43descendants
- K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation · 2016 · 4 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| 0 (this device) | K110789 | Synthes Sternal Zipfix System | Synthes (Usa) | 2011 | — |
| +1 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| +2 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| +1 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| +3 | K151019 | SternaLock® 360 Sternal Closure System | Biomet Microfixation | 2015 | — |
| +4 | K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | Biomet Microfixation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 16 | 0 |
| 2025 | 15 | 0 |
| 2026 | 13 | 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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 |
|---|---|---|---|
| * | K931271 | Ethi-Pack* Surgical Stainless Steel SutureSummary page 1…Cerelage Regulation 21 CFR §888.3010 Number Device Class 2 Review Panel Orthopedic Product Codes Primary: JDQ Predicate Devices K93 127 1- Ethicon Stainless Steel Suture Wire K946 173- Ethicon Stainless Steel Suture Wire K093… | 1994 |
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 1…ss 2 Review Panel Orthopedic Product Codes Primary: JDQ Predicate Devices K93 127 1- Ethicon Stainless Steel Suture Wire K946 173- Ethicon Stainless Steel Suture Wire K093772 - Synthes Sternal Fixation System Device The Syn… | 1995 |
| * | K093772 | Synthes Sternal Fixation SystemSummary page 1…Primary: JDQ Predicate Devices K93 127 1- Ethicon Stainless Steel Suture Wire K946 173- Ethicon Stainless Steel Suture Wire K093772 - Synthes Sternal Fixation System Device The Synthes Sternal ZipFxTM System consists of polyetheretherketone Desc… | 2010 |
What descends from it? (85)
See all 856 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111908 | Biomet Microfixation Sternal Closure System | 2011 | 78 |
| K151983 | KLS Martin LSS Plating System | 2016 | 45 |
| K211613 | Stern Fix Sternal Stabilization System | 2022 | 1 |
| K232986 | VariTrax Sternal CircumFixation System | 2024 | 0 |
| K120016 | Pioneer Sternal Assist Implant System | 2012 | 0 |
| K120177 | Spinal Elements Cerclage System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2015 | Class II | Z-0276-2016 | Device Design | Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired… |
| Jul 22, 2015 | Class II | Z-2475-2015 | Device Design | The end cap may loosen and detach making the instrument non-functional. No injuries reported. |
| Aug 13, 2013 | Class II | Z-0114-2014 | Labeling False and Misleading | When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Synthes Sternal ZipFixTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110789: Synthes Sternal Zipfix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110789
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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