510(k) · Cleared
ClearedTeno Fix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortheon Medical, LLC · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on May 15, 2003 as substantially equivalent to K931271 (ETHICON, Inc., 1994) and 1 other predicate after a 202-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.
- Decided
- May 15, 2003
- Review
- 202 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931271 (1994). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- 1 generation backK991073 Acier SuturesCardio Thoracic Systems · 1999
- This deviceK023594 Teno FixOrtheon Medical, LLC · 2003
- Descendant · cites it directly · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
- Descendant · cites it directly · 0 of its ownK203855 CoNextions TR Tendon Repair SystemConextions Medical · 2022
- Descendant · 3 generations on · 0 of its ownK143582 Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide…Resorba Medical GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK141711 Pontis 3MM Suture Anchors with Ultra-High Molecular Weight…Pontis Orthopaeeics, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · cites it directly3descendants
- K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · 2 generations on1descendant
- K203855CoNextions TR Tendon Repair SystemConextions Medical · 2022 · cites it directly0descendants
- K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015 · 3 generations on0descendants
- K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| −1 | K991073 | Acier Sutures | Cardio Thoracic Systems | 1999 | — |
| 0 (this device) | K023594 | Teno Fix | Ortheon Medical, LLC | 2003 | — |
| +1 | K101126 | Pontis Sutures and Suture Anchors with Optional Crimps | Core Essence Orthopaedics, Inc. | 2010 | — |
| +2 | K140127 | Ferrofibre Stainless Steel Suture with Crimp | Pontis Orthopaedics, LLC | 2014 | — |
| +1 | K203855 | CoNextions TR Tendon Repair System | Conextions Medical | 2022 | — |
| +3 | K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel | Resorba Medical GmbH | 2015 | — |
| +2 | K141711 | Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene… | Pontis Orthopaeeics, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 K203855 CoNextions TR Tendon Repair Systemscore 3.8 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K931271 | Ethi-Pack* Surgical Stainless Steel SutureSummary page 1…r system is substantially equivalent to the Surgical Stainless Steel Sutures manufactured and marketed by Ethicon Incorporated, a Johnson & Johnson Company pursuant to K931271, as well as to the Surgical Stainless Steel Sutures manufactured by Peters Pharmaceutical Laboratory and marketed in the USA by… | 1994 |
| * | K991073 | Acier SuturesSummary page 1…tainless Steel Sutures manufactured by Peters Pharmaceutical Laboratory and marketed in the USA by CardioThoracic Systems, Inc., under the Acier brand name pursuant to K991073. The Ten0 FixTMtendon repair system is also substantially equivalent to Prolene sutures, which are also manufactured and market… | 1999 |
| * | — | Prolene sutures Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101126 (Core Essence Orthopaedics, Inc., 2010) has gone furthest, with 3 descendants of its own.
- 18 other devices also cite its predicate K931271.
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.
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?
The Ortheon Medical Ten0 Fixm Tendon Repair System is intended for the repair of severed or lacerated digital flexor tendons.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023594: Teno Fix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023594
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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