510(k) · Cleared
ClearedArthrex SoftStitch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Oct 2, 2020 as substantially equivalent to K132043 (Arthrex, Inc., 2013) and 1 other predicate after a 563-day review. Its family tree reaches back 6 generations to 1993. 2 later devices descend from it.
- Decided
- Oct 2, 2020
- Review
- 563 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K925573 (1993). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 5 generations backK002261 MR-IIISmith & Nephew, Inc. · 2000
- 4 generations backK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
- 3 generations backK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
- 2 generations backK073149 Meniscal CinchArthrex, Inc. · 2008
- 1 generation backK132043 Arthrex SpeedcinchArthrex, Inc. · 2013
- This deviceK190707 Arthrex SoftStitchArthrex, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK243480 SuturePatch Tissue ReinforcementArthrex, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK222078 Arthrex SoftStitchArthrex, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −5 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| −4 | K020480 | RBM | Smith & Nephew, Inc. | 2002 | 1 |
| −3 | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| −2 | K073149 | Meniscal Cinch | Arthrex, Inc. | 2008 | — |
| −1 | K132043 | Arthrex Speedcinch | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020 | — |
| +1 | K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | 2025 | — |
| +1 | K222078 | Arthrex SoftStitch | Arthrex, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K132043 | Arthrex SpeedcinchSummary page 4…e surgical suture Classification Name 21 CFR 878.5000 – Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class II Predicate Device K132043: Arthrex SpeedCinch K073149: Arthrex Meniscal Cinch Reference Device K052900: Quill Nonabsorbable… | 2013 |
| * | K073149 | Meniscal CinchSummary page 4….5000 – Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class II Predicate Device K132043: Arthrex SpeedCinch K073149: Arthrex Meniscal Cinch Reference Device K052900: Quill Nonabsorbable Nylon Barbed Suture K181769:… | 2008 |
| † | K052900 | Quill Nonabsorbable Nylon Barbed Suture | 2005 |
| † | K181769 | Arthrex FiberTak Suture Anchor | 2018 |
| † | K162396 | SILK Surgical Suture | 2016 |
What descends from it? (2)
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 27 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K243480 (Arthrex, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132043.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190707: Arthrex SoftStitch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190707
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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