510(k) · Cleared
ClearedStern Fix Sternal Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neos Surgery S.L · JDQ Cerclage, Fixation
Cleared on Jan 19, 2022 as substantially equivalent to K110789 (Synthes (Usa), 2011) after a 238-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 19, 2022
- Review
- 238 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931271 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- 1 generation backK110789 Synthes Sternal Zipfix SystemSynthes (Usa) · 2011 · Recalled
- This deviceK211613 Stern Fix Sternal Stabilization SystemNeos Surgery S.L · 2022
- Descendant · cites it directly · 0 of its ownK221795 STERN FIX Sternal Stabilization SystemNeos Surgery S.L · 2022
Most influential descendants
Showing 1 of 1 · See all- K221795STERN FIX Sternal Stabilization SystemNeos Surgery S.L · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| −1 | K110789 | Synthes Sternal Zipfix System | Synthes (Usa) | 2011 | 3 |
| 0 (this device) | K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | 2022 | — |
| +1 | K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K110789 | Synthes Sternal Zipfix SystemSummary page 6…Common Name: Cerclage, fixation Regulatory Class: II Regulation: 888.3010 Bone fixation cerclage Product Codes: JDQ Predicate Device(s): SYNTHES STERNAL ZIPFIX SYSTEM - K110789 Reference Device: KLS MARTIN STERNAL TALON- K051165 Device Description The STERN FIX is a long-term implantable postoperative st… | 2011 |
| † | K051165 | KLS Martin Sternal Talon | 2006 |
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 |
|---|---|---|---|
| K221795 | STERN FIX Sternal Stabilization System | 2022 | 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 28 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K221795 (Neos Surgery S.L, 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K110789.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its 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/K211613 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211613: Stern Fix Sternal Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211613
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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