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 Oct 19, 2022 as substantially equivalent to K211613 (Neos Surgery S.L, 2022) after a 120-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Oct 19, 2022
- Review
- 120 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931271 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- 2 generations backK110789 Synthes Sternal Zipfix SystemSynthes (Usa) · 2011 · Recalled
- 1 generation backK211613 Stern Fix Sternal Stabilization SystemNeos Surgery S.L · 2022
- This deviceK221795 STERN FIX Sternal Stabilization SystemNeos Surgery S.L · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| −2 | K110789 | Synthes Sternal Zipfix System | Synthes (Usa) | 2011 | 3 |
| −1 | K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K211613 | Stern Fix Sternal Stabilization SystemSummary page 4…clage, fixation Regulatory Class: II Regulation: 888.3010 Bone fixation cerclage Product Codes: JDQ Primary Predicate Device(s): STERN FIX Sternal Stabilization System – K211613 Device Description The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilize… | 2022 |
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 28 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
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 as stated in the FDA summary.
https://510kreport.com/device/K221795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221795: STERN FIX Sternal Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221795
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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