510(k) · Cleared
ClearedSic Brevetti S.R.L. Device for Sternal Synthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sic Brevetti S.R.L. · JDQ Cerclage, Fixation
Cleared on Dec 8, 2009 as substantially equivalent to K063017 (Aesculap, Inc., 2006) and 4 other predicates after a 267-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Dec 8, 2009
- Review
- 267 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K875156 (1988). 26 ancestors in all, the oldest K844068 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK875156 Stainless Steel Orthopaedic Cable SystemRichards Medical Co., Inc. · 1988
- 4 generations backK961283 Dall-Miles Homogenous Vitallium CableHowmedica Corp. · 1996
- 3 generations backK972327 Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997
- 2 generations backK983976 Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
- 1 generation backK063009 Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None…Praesidia S.R.L. · 2006
- This deviceK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K875156 | Stainless Steel Orthopaedic Cable System | Richards Medical Co., Inc. | 1988 | — |
| −4 | K961283 | Dall-Miles Homogenous Vitallium Cable | Howmedica Corp. | 1996 | — |
| −3 | K972327 | Metagen Activelock Cerclage System | Pacific Materials and Interfaces | 1997 | — |
| −2 | K983976 | Metagen Activelock Wire Cerclage System | Metagen, LLC | 1998 | — |
| −1 | K063009 | Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes) | Praesidia S.R.L. | 2006 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (5)
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 |
|---|---|---|---|
| * | K063017 | Aesculap Sternumfix Sternal Closure SystemSummary page 1…rbable, steel, monofilamnent and multifilament, sterile 3. PREDICATE DEVICES * SternumFix Sternal Closure System (K063017) * Flexigrip Sternal Closure System (K063009) * Ethicon Stainless Steel Suture (K931271 and K946173)… | 2006 |
| * | K063009 | Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)Summary page 1…monofilamnent and multifilament, sterile 3. PREDICATE DEVICES * SternumFix Sternal Closure System (K063017) * Flexigrip Sternal Closure System (K063009) * Ethicon Stainless Steel Suture (K931271 and K946173) *SuturTek Stainless Steel Suture (K063603) 4. DE… | 2006 |
| * | K931271 | Ethi-Pack* Surgical Stainless Steel SutureSummary page 1…ICATE DEVICES * SternumFix Sternal Closure System (K063017) * Flexigrip Sternal Closure System (K063009) * Ethicon Stainless Steel Suture (K931271 and K946173) *SuturTek Stainless Steel Suture (K063603) 4. DEVICE DESCRIPTION The Device for Sternal Synthe… | 1994 |
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 1…S * SternumFix Sternal Closure System (K063017) * Flexigrip Sternal Closure System (K063009) * Ethicon Stainless Steel Suture (K931271 and K946173) *SuturTek Stainless Steel Suture (K063603) 4. DEVICE DESCRIPTION The Device for Sternal Synthesis is a sur… | 1995 |
| * | K063603 | Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Summary page 1…3017) * Flexigrip Sternal Closure System (K063009) * Ethicon Stainless Steel Suture (K931271 and K946173) *SuturTek Stainless Steel Suture (K063603) 4. DEVICE DESCRIPTION The Device for Sternal Synthesis is a surgical implant that is available in two sizes ma… | 2007 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 26 ancestors has 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. 2009, 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 Device for Sternal Synthesis is indicated for closure and repair of the sternum after sternotomy to stabilize the sternum and promote fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090686 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090686: Sic Brevetti S.R.L. Device for Sternal Synthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090686
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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