510(k) · Cleared
ClearedCoNextions TR Tendon Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conextions Medical · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Apr 22, 2022 as substantially equivalent to K023594 (Ortheon Medical, LLC, 2003) and 1 other predicate after a 477-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 22, 2022
- Review
- 477 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931271 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- 2 generations backK991073 Acier SuturesCardio Thoracic Systems · 1999
- 1 generation backK023594 Teno FixOrtheon Medical, LLC · 2003
- This deviceK203855 CoNextions TR Tendon Repair SystemConextions Medical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| −2 | K991073 | Acier Sutures | Cardio Thoracic Systems | 1999 | — |
| −1 | K023594 | Teno Fix | Ortheon Medical, LLC | 2003 | — |
| 0 (this device) | K203855 | CoNextions TR Tendon Repair System | Conextions Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 GAQ? 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 GAQ device
- #1 K193209 Wego-Stainless Steelscore -0.8 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K023594 | Teno FixSummary page 4…ilament, Sterile Classification Name: Stainless Steel Suture Regulatory Class: Product Code: Predicate Devices: Reference Devices: Device Description Class I GAQ K023594, Teno Fix™ Tendon Repair System, Ortheon Medical, LLC. (Primary) K946173, PROLENE™ Polypropylene Nonabsorble Suture, Ethicon, In… | 2003 |
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 4…Class: Product Code: Predicate Devices: Reference Devices: Device Description Class I GAQ K023594, Teno Fix™ Tendon Repair System, Ortheon Medical, LLC. (Primary) K946173, PROLENE™ Polypropylene Nonabsorble Suture, Ethicon, Inc. K041553, Arthrex Fiberwire, Arthrex, Inc. K930591, TiCron™ Suture, Tyc… | 1995 |
| † | K041553 | Arthrex Suture Grafting Kit | 2004 |
| † | K930591 | TI-Cron and Dacron Sutures | 1993 |
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 28 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K023594.
How does its category compare?
All GAQ devicesGAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GAQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GAQ
Too few GAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GAQ
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAQ
83in 2025
MAUDE reports naming product code GAQ, 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 | 7 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 2 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 23 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 52 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 100 |
| 2024 | 0 | — | 0 | 176 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
CoNextions TR Tendon Repair System is indicated for the repair of severed or lacerated Tendons in adults (22 years of age or older). The product is intended for the following indications:
» Digital Flexor Tendons
» Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)
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/K203855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203855: CoNextions TR Tendon Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203855
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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