510(k) · Cleared
ClearedAesculap Sternumfix Sternal Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · JDQ Cerclage, Fixation
Cleared on Dec 27, 2006 as substantially equivalent to K931271 (ETHICON, Inc., 1994) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Dec 27, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K923705 (1994). 5 ancestors in all, the oldest K931271 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK923705 Aesculap Craniofacial Titanium Plates and ScrewsAesculap, Inc. · 1994
- 1 generation backK040864 Craniofix and CRANIOFIX2 Titanium Clamp SystemAesculap · 2004
- This deviceK063017 Aesculap Sternumfix Sternal Closure SystemAesculap, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923705 | Aesculap Craniofacial Titanium Plates and Screws | Aesculap, Inc. | 1994 | — |
| −1 | K040864 | Craniofix and CRANIOFIX2 Titanium Clamp System | Aesculap | 2004 | — |
| 0 (this device) | K063017 | Aesculap Sternumfix Sternal Closure System | Aesculap, Inc. | 2006 | — |
| +1 | K090686 | Sic Brevetti S.R.L. Device for Sternal Synthesis | Sic Brevetti S.R.L. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K931271 | Ethi-Pack* Surgical Stainless Steel SutureSummary page 1…SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the SternumFix Sternal Closure System is substantially equivalent to: 1) Ethicon Stainless Steel Suture Wire (K931271/ K946173) 2) Aesculap CranioFix Titanium Clamp System (K040864) 3) Synthes Sternal Fixation System (KOI10943) DEVICE DES… | 1994 |
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 1…NTIAL EQUIVALENCE Aesculap®, Inc. believes that the SternumFix Sternal Closure System is substantially equivalent to: 1) Ethicon Stainless Steel Suture Wire (K931271/ K946173) 2) Aesculap CranioFix Titanium Clamp System (K040864) 3) Synthes Sternal Fixation System (KOI10943) DEVICE DESCRIPTION… | 1995 |
| * | K040864 | Craniofix and CRANIOFIX2 Titanium Clamp SystemSummary page 1…umFix Sternal Closure System is substantially equivalent to: 1) Ethicon Stainless Steel Suture Wire (K931271/ K946173) 2) Aesculap CranioFix Titanium Clamp System (K040864) 3) Synthes Sternal Fixation System (KOI10943) DEVICE DESCRIPTION The Aesculap SternumFix Sternal Closure System consists o… | 2004 |
| Kept off the family tree | K011094 | Synthes Sternal Fixation System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree |
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 |
|---|---|---|---|
| K090686 | Sic Brevetti S.R.L. Device for Sternal Synthesis | 2009 | 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 12 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K090686 (Sic Brevetti S.R.L., 2009) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K931271.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Aesculap SternumFix Sternal Closure 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/K063017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063017: Aesculap Sternumfix Sternal Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063017
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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