510(k) · Cleared
ClearedStitch Cerclage – Suture Tapes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GM Dos Reis Industria e Comercio Ltda. · JDQ Cerclage, Fixation
Cleared on Aug 14, 2025 as substantially equivalent to K221485 (Arthrex, Inc., 2022) after a 238-day review. Its family tree reaches back 10 generations to 1979.
- Decided
- Aug 14, 2025
- Review
- 238 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K792022 (1979). 71 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- 1 generation backK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
- This deviceK243905 Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- 1 generation backK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
- This deviceK243905 Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −3 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −2 | K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019 | — |
| −1 | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022 | — |
| 0 (this device) | K243905 | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K221485 | Arthrex FiberTape and TigerTape Cerclage SuturesSummary page 5…dicate Devices: Legally marketed device to which we are claiming “Substantial Equivalence” are the following: Arthrex FiberTape and TigerTape Cerclage Sutures - Arthrex (K221485) (Predicate Device) Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors - GMReis (K223114) (Reference Device) EXPERT -… | 2022 |
| † | K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | 2023 |
| † | K200332 | EXPERT - Joint Fixation System | 2020 |
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 46 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 71 ancestors have a recall of any class.
- 2 other devices also cite its predicate K221485.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:
» Sternotomy indications including the "rewiring" of osteomized sternums;
» Repair of long bone fractures due to trauma or reconstruction.
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/K243905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243905: Stitch Cerclage – Suture Tapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243905
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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