510(k) · Cleared
ClearedCompressyn Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dallen Medical, Inc. · JDQ Cerclage, Fixation
Cleared on Jul 25, 2013 as substantially equivalent to K101484 (Dallen Medical, 2011) after a 154-day review. Its family tree reaches back 10 generations to 1976. 4 later devices descend from it.
- Decided
- Jul 25, 2013
- Review
- 154 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K761228 (1976). 85 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- 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 backK101484 Compressyn BandDallen Medical · 2011
- This deviceK130431 Compressyn BandDallen Medical, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK133858 Tensyn BandDallen Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK141264 Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK143092 Tensyn PlugDallen Medical, Inc. · 2015
- Descendant · 4 generations on · 0 of its ownK150359 Tensyn PlugDallen Medical, Inc. · 2015
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 backK101484 Compressyn BandDallen Medical · 2011
- This deviceK130431 Compressyn BandDallen Medical, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K133858Tensyn BandDallen Medical, Inc. · 2014 · cites it directly3descendants
- K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc. · 2014 · 2 generations on2descendants
- K143092Tensyn PlugDallen Medical, Inc. · 2015 · 3 generations on1descendant
- K150359Tensyn PlugDallen Medical, Inc. · 2015 · 4 generations on0descendants
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 | K101484 | Compressyn Band | Dallen Medical | 2011 | — |
| 0 (this device) | K130431 | Compressyn Band | Dallen Medical, Inc. | 2013 | — |
| +1 | K133858 | Tensyn Band | Dallen Medical, Inc. | 2014 | — |
| +2 | K141264 | Tensyn Band, Tensyn Fracture Plates | Dallen Medical, Inc. | 2014 | — |
| +3 | K143092 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
| +4 | K150359 | Tensyn Plug | Dallen Medical, Inc. | 2015 | — |
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 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K101484 | Compressyn BandSummary page 1…IFICATION NAME: Bone Fixation, Cerciage, CFR 888.3010 (code ADO) DEVICE CLASSIFICATION: Class 11 PREDICATE DEVICES: Compressyn m Band (K101484) Product Description: The Compressynm" Band System consists of a stainless steel coupler preloaded with a polymer coated poly… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133858 | Tensyn Band | 2014 | 3 |
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 37 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 85 ancestors have a recall of any class.
- Of its descendants, K133858 (Dallen Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Compressyn Tm Band is intended for use in stabilization and fixation of anterior chest wail fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130431: Compressyn Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130431
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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