510(k) · Cleared
ClearedArthrex Speedcinch
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 Jul 31, 2013 as substantially equivalent to K073149 (Arthrex, Inc., 2008) after a 29-day review. Its family tree reaches back 5 generations to 1993. 6 later devices descend from it.
- Decided
- Jul 31, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K925573 (1993). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 4 generations backK002261 MR-IIISmith & Nephew, Inc. · 2000
- 3 generations backK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
- 2 generations backK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
- 1 generation backK073149 Meniscal CinchArthrex, Inc. · 2008
- This deviceK132043 Arthrex SpeedcinchArthrex, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK190707 Arthrex SoftStitchArthrex, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK243480 SuturePatch Tissue ReinforcementArthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK244015 SuperBall-RC™Arcuro Medical, Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190707Arthrex SoftStitchArthrex, Inc. · 2020 · cites it directly2descendants
- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · cites it directly2descendants
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 2 generations on1descendant
- K243480SuturePatch Tissue ReinforcementArthrex, Inc. · 2025 · 2 generations on0descendants
- K244015SuperBall-RC™Arcuro Medical, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −4 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| −3 | K020480 | RBM | Smith & Nephew, Inc. | 2002 | 1 |
| −2 | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| −1 | K073149 | Meniscal Cinch | Arthrex, Inc. | 2008 | — |
| 0 (this device) | K132043 | Arthrex Speedcinch | Arthrex, Inc. | 2013 | — |
| +1 | K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020 | — |
| +1 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
| +2 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2022 | — |
| +2 | K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | 2025 | — |
| +3 | K244015 | SuperBall-RC™ | Arcuro Medical, Ltd. | 2025 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K073149 | Meniscal CinchSummary page 1…21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predcat Deice K073149: Arthrex M eniscal Cinch Purpose of Submission This special 510(k) premarket notification is submitted to… | 2008 |
What descends from it? (6)
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 20 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K190707 (Arthrex, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K073149.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SpeedCinch 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/K132043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132043: Arthrex Speedcinch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132043
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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