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 Sep 14, 2022 as substantially equivalent to K190707 (Arthrex, Inc., 2020) after a 62-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Sep 14, 2022
- Review
- 62 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K925573 (1993). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 6 generations backK002261 MR-IIISmith & Nephew, Inc. · 2000
- 5 generations backK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
- 4 generations backK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
- 3 generations backK073149 Meniscal CinchArthrex, Inc. · 2008
- 2 generations backK132043 Arthrex SpeedcinchArthrex, Inc. · 2013
- 1 generation backK190707 Arthrex SoftStitchArthrex, Inc. · 2020
- This deviceK222078 Arthrex SoftStitchArthrex, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −6 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| −5 | K020480 | RBM | Smith & Nephew, Inc. | 2002 | 1 |
| −4 | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| −3 | K073149 | Meniscal Cinch | Arthrex, Inc. | 2008 | — |
| −2 | K132043 | Arthrex Speedcinch | Arthrex, Inc. | 2013 | — |
| −1 | K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K222078 | Arthrex SoftStitch | Arthrex, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K190707 | Arthrex SoftStitchSummary page 4…Classification Name 21 CFR 878.5000 – Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class II Primary Predicate Device K190707: Arthrex SoftStitch Reference Device K203117: TissueTak Device Purpose of Submission This Traditional 510(… | 2020 |
| † | K203117 | TissueTak device | 2021 |
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 29 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K190707.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222078: 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/K222078
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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