510(k) · Cleared
ClearedVariTrax Sternal CircumFixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circumfix Solutions, Inc. · JDQ Cerclage, Fixation
Cleared on Jan 30, 2024 as substantially equivalent to K110789 (Synthes (Usa), 2011) and 2 other predicates after a 130-day review. Its family tree reaches back 10 generations to 1976.
- Decided
- Jan 30, 2024
- Review
- 130 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K761228 (1976). 86 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations between
- 3 generations backK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
- 2 generations backK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- 1 generation backK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- This deviceK232986 VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 9 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 8 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 7 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 6 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 5 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 4 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 3 generations backK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
- 2 generations backK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- 1 generation backK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- This deviceK232986 VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −9 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −8 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −7 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −6 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −5 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −4 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −3 | K051165 | KLS Martin Sternal Talon | KLS-Martin L.P. | 2006 | — |
| −2 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| −1 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| 0 (this device) | K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K110789 | Synthes Sternal Zipfix SystemSummary page 4…nent metallic bone fixation appliances and accessories Product Code: JDQ (Primary), HRS Predicate Devices: K110789 Synthes Sternal ZipFix System (primary) K946173 Ethicon Stainless Steel Suture Wire (additional)… | 2011 |
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 4…ne fixation appliances and accessories Product Code: JDQ (Primary), HRS Predicate Devices: K110789 Synthes Sternal ZipFix System (primary) K946173 Ethicon Stainless Steel Suture Wire (additional) K151983 KLS Mart… | 1995 |
| * | K151983 | KLS Martin LSS Plating SystemSummary page 4…Predicate Devices: K110789 Synthes Sternal ZipFix System (primary) K946173 Ethicon Stainless Steel Suture Wire (additional) K151983 KLS Martin LSS Plating System (additional) Device Description: The VariTrax Sternal CircumFixati… | 2016 |
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 48 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 86 ancestors have a recall of any class.
- 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. 2024, 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 VariTrax Sternal CircumFixation system is indicated for 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/K232986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232986: VariTrax Sternal CircumFixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232986
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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