510(k) · Cleared
Recalled · Class II · 2019Thorecon Rigid Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A & E Medical Corporation · JDQ Cerclage, Fixation
Cleared on Oct 12, 2018 as substantially equivalent to K173579 (A & E Medical Corporation, 2018) after a 115-day review. Its family tree reaches back 14 generations to 1976. It has been recalled 5 times.
- Decided
- Oct 12, 2018
- Review
- 115 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 14 generations to K761228 (1976). 37 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 10 generations between
- 3 generations backK150581 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
- 2 generations backK161876 Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
- 1 generation backK173579 Thorecon™ Fixation SystemA & E Medical Corporation · 2018
- This deviceK181607 Thorecon Rigid Fixation SystemA & E Medical Corporation · 2018
Show all 14 generations
- Root · 14 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 13 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 12 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 11 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 10 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 9 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 8 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 7 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 6 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 5 generations backK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
- 4 generations backK133785 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · Recalled
- 3 generations backK150581 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
- 2 generations backK161876 Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
- 1 generation backK173579 Thorecon™ Fixation SystemA & E Medical Corporation · 2018
- This deviceK181607 Thorecon Rigid Fixation SystemA & E Medical Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −13 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −12 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −11 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −10 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −9 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −8 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −7 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −6 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −5 | K122293 | Pioneer Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2012 | — |
| −4 | K133785 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2014 | 1 |
| −3 | K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015 | — |
| −2 | K161876 | Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016 | — |
| −1 | K173579 | Thorecon™ Fixation System | A & E Medical Corporation | 2018 | — |
| 0 (this device) | K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K173579 | Thorecon™ Fixation SystemSummary page 4…21 CFR 878.4495 (GAQ, Suture, Nonabsorbable, Steel, Monofilament and multifilament, Sterile) Panel: Panel Code 87 Predicate: K173579 Thorecon Fixation System Description: The Thorecon Rigid Fixation System may be implanted via an open or m… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2019 | Class II | Z-0243-2020 | Process control | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable. |
| Sep 10, 2019 | Class II | Z-0244-2020 | Process control | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable. |
| Sep 10, 2019 | Class II | Z-0242-2020 | Process control | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable. |
| Sep 10, 2019 | Class II | Z-0245-2020 | Process control | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable. |
| Sep 10, 2019 | Class II | Z-0246-2020 | Process control | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 37 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. 2018, 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 Thorecon Rigid Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.
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/K181607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181607: Thorecon Rigid Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181607
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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